Time Frame |
Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years.
|
Adverse Event Reporting Description |
All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
|
|
Arm/Group Title
|
Extreme Risk: TAVI Iliofemoral
|
Extreme Risk: TAVI Non-Iliofemoral
|
High Risk: TAVI
|
Arm/Group Description |
Extreme Risk Patients: Medtronic Co...
|
Extreme Risk Patients: Medtronic Co...
|
High Risk Surgical Patients: Medtro...
|
Arm/Group Description |
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
|
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
|
High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
|
|
|
Extreme Risk: TAVI Iliofemoral
|
Extreme Risk: TAVI Non-Iliofemoral
|
High Risk: TAVI
|
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Total |
--/--
|
|
--/--
|
|
--/--
|
|
|
|
Extreme Risk: TAVI Iliofemoral
|
Extreme Risk: TAVI Non-Iliofemoral
|
High Risk: TAVI
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
1117/1257 (88.86%)
|
|
359/367 (97.82%)
|
|
1004/1108 (90.61%)
|
|
Blood and lymphatic system disorders |
|
|
|
Anaemia Deficiencies |
7/1257 (0.56%)
|
7 |
3/367 (0.82%)
|
3 |
6/1108 (0.54%)
|
6 |
Anaemias Due To Chronic Disorders |
2/1257 (0.16%)
|
2 |
3/367 (0.82%)
|
3 |
2/1108 (0.18%)
|
2 |
Anaemias |
340/1257 (27.05%)
|
420 |
150/367 (40.87%)
|
182 |
265/1108 (23.92%)
|
319 |
Coagulopathies |
9/1257 (0.72%)
|
9 |
6/367 (1.63%)
|
6 |
6/1108 (0.54%)
|
6 |
Haemolyses |
0/1257 (0.00%)
|
0 |
1/367 (0.27%)
|
1 |
1/1108 (0.09%)
|
1 |
Leukocytoses |
9/1257 (0.72%)
|
9 |
4/367 (1.09%)
|
4 |
13/1108 (1.17%)
|
13 |
Lymphatic System Disorders |
0/1257 (0.00%)
|
0 |
1/367 (0.27%)
|
1 |
1/1108 (0.09%)
|
1 |
Marrow Depression And Hypoplastic Anaemias |
3/1257 (0.24%)
|
3 |
4/367 (1.09%)
|
7 |
2/1108 (0.18%)
|
2 |
Spleen Disorders |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
2/1108 (0.18%)
|
2 |
Thrombocytopenias |
34/1257 (2.70%)
|
34 |
17/367 (4.63%)
|
17 |
20/1108 (1.81%)
|
21 |
Cardiac disorders |
|
|
|
Aortic Valvular Disorders |
143/1257 (11.38%)
|
153 |
26/367 (7.08%)
|
29 |
103/1108 (9.30%)
|
108 |
Cardiac Conduction Disorders |
293/1257 (23.31%)
|
311 |
63/367 (17.17%)
|
66 |
277/1108 (25.00%)
|
296 |
Cardiac Disorders |
13/1257 (1.03%)
|
13 |
5/367 (1.36%)
|
5 |
13/1108 (1.17%)
|
13 |
Cardiac Signs And Symptoms |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
3/1108 (0.27%)
|
3 |
Cardiac Valve Disorders |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Cardiomyopathies |
16/1257 (1.27%)
|
16 |
3/367 (0.82%)
|
3 |
6/1108 (0.54%)
|
7 |
Coronary Artery Disorders |
26/1257 (2.07%)
|
28 |
7/367 (1.91%)
|
8 |
10/1108 (0.90%)
|
11 |
Heart Failures |
329/1257 (26.17%)
|
531 |
105/367 (28.61%)
|
147 |
248/1108 (22.38%)
|
346 |
Ischaemic Coronary Artery Disorders |
91/1257 (7.24%)
|
102 |
26/367 (7.08%)
|
30 |
78/1108 (7.04%)
|
97 |
Left Ventricular Failures |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Mitral Valvular Disorders |
36/1257 (2.86%)
|
37 |
3/367 (0.82%)
|
3 |
28/1108 (2.53%)
|
30 |
Myocardial Disorders |
6/1257 (0.48%)
|
6 |
5/367 (1.36%)
|
5 |
9/1108 (0.81%)
|
9 |
Pericardial Disorders |
22/1257 (1.75%)
|
24 |
8/367 (2.18%)
|
9 |
30/1108 (2.71%)
|
33 |
Pulmonary Valvular Disorders |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Rate And Rhythm Disorders |
75/1257 (5.97%)
|
77 |
20/367 (5.45%)
|
21 |
50/1108 (4.51%)
|
54 |
Right Ventricular Failures |
4/1257 (0.32%)
|
4 |
1/367 (0.27%)
|
1 |
4/1108 (0.36%)
|
4 |
Supraventricular Arrhythmias |
152/1257 (12.09%)
|
184 |
47/367 (12.81%)
|
55 |
119/1108 (10.74%)
|
137 |
Tricuspid Valvular Disorders |
11/1257 (0.88%)
|
11 |
1/367 (0.27%)
|
1 |
5/1108 (0.45%)
|
5 |
Ventricular Arrhythmias And Cardiac Arrest |
139/1257 (11.06%)
|
150 |
43/367 (11.72%)
|
49 |
104/1108 (9.39%)
|
113 |
Congenital, familial and genetic disorders |
|
|
|
Cardiac Malpositions Congenital |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Cardiac Septal Defects Congenital |
2/1257 (0.16%)
|
3 |
0/367 (0.00%)
|
0 |
3/1108 (0.27%)
|
3 |
Cardiovascular Disorders Congenital |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Male Reproductive Tract Disorders Congenital |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Vascular Anomalies Congenital |
2/1257 (0.16%)
|
2 |
1/367 (0.27%)
|
1 |
0/1108 (0.00%)
|
0 |
Ear and labyrinth disorders |
|
|
|
Eustachian Tube Disorders |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
External Ear Disorders |
2/1257 (0.16%)
|
2 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Inner Ear Signs And Symptoms |
7/1257 (0.56%)
|
7 |
3/367 (0.82%)
|
3 |
2/1108 (0.18%)
|
2 |
Middle Ear Disorders |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Endocrine disorders |
|
|
|
Thyroid Disorders |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Thyroid Hyperfunction Disorders |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Thyroid Hypofunction Disorders |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
4/1108 (0.36%)
|
4 |
Eye disorders |
|
|
|
Blindness (Excl Colour Blindness) |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Cataract Conditions |
5/1257 (0.40%)
|
6 |
0/367 (0.00%)
|
0 |
6/1108 (0.54%)
|
6 |
Conjunctival And Corneal Bleeding And Vascular Disorders |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Corneal Structural Change, Deposit And Degeneration |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Lens Structural Change, Deposit And Degeneration (Excl Cataracts) |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Lid, Lash And Lacrimal Structural Disorders |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Ocular Bleeding And Vascular Disorders |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
2/1108 (0.18%)
|
3 |
Partial Vision Loss |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Retinal Bleeding And Vascular Disorders (Excl Retinopathy) |
3/1257 (0.24%)
|
3 |
0/367 (0.00%)
|
0 |
4/1108 (0.36%)
|
4 |
Retinal Structural Change, Deposit And Degeneration |
2/1257 (0.16%)
|
2 |
0/367 (0.00%)
|
0 |
2/1108 (0.18%)
|
2 |
Retinal, Choroid And Vitreous Infections And Inflammations |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Visual Disorders |
2/1257 (0.16%)
|
2 |
2/367 (0.54%)
|
2 |
3/1108 (0.27%)
|
3 |
Gastrointestinal disorders |
|
|
|
Abdominal Findings Abnormal |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Abdominal Hernias, Site Unspecified |
3/1257 (0.24%)
|
3 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Abdominal Wall Conditions |
1/1257 (0.08%)
|
1 |
1/367 (0.27%)
|
1 |
2/1108 (0.18%)
|
2 |
Acute And Chronic Pancreatitis |
1/1257 (0.08%)
|
1 |
1/367 (0.27%)
|
1 |
0/1108 (0.00%)
|
0 |
Anal And Rectal Pains |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Benign Neoplasms Gastrointestinal (Excl Oral Cavity) |
2/1257 (0.16%)
|
2 |
0/367 (0.00%)
|
0 |
2/1108 (0.18%)
|
2 |
Colitis (Excl Infective) |
4/1257 (0.32%)
|
5 |
3/367 (0.82%)
|
3 |
4/1108 (0.36%)
|
4 |
Dental And Periodontal Infections And Inflammations |
2/1257 (0.16%)
|
2 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Dental Disorders |
1/1257 (0.08%)
|
1 |
1/367 (0.27%)
|
1 |
0/1108 (0.00%)
|
0 |
Diaphragmatic Hernias |
2/1257 (0.16%)
|
2 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Diarrhoea (Excl Infective) |
9/1257 (0.72%)
|
9 |
2/367 (0.54%)
|
2 |
5/1108 (0.45%)
|
5 |
Diverticula |
3/1257 (0.24%)
|
3 |
2/367 (0.54%)
|
2 |
4/1108 (0.36%)
|
4 |
Duodenal And Small Intestinal Stenosis And Obstruction |
7/1257 (0.56%)
|
7 |
1/367 (0.27%)
|
1 |
5/1108 (0.45%)
|
7 |
Duodenal Ulcers And Perforation |
4/1257 (0.32%)
|
4 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Dyspeptic Signs And Symptoms |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Faecal Abnormalities |
2/1257 (0.16%)
|
2 |
0/367 (0.00%)
|
0 |
9/1108 (0.81%)
|
9 |
Flatulence, Bloating And Distension |
2/1257 (0.16%)
|
2 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Gastric And Oesophageal Haemorrhages |
3/1257 (0.24%)
|
3 |
0/367 (0.00%)
|
0 |
2/1108 (0.18%)
|
2 |
Gastric Ulcers And Perforation |
5/1257 (0.40%)
|
5 |
1/367 (0.27%)
|
1 |
0/1108 (0.00%)
|
0 |
Gastritis (Excl Infective) |
5/1257 (0.40%)
|
5 |
3/367 (0.82%)
|
3 |
2/1108 (0.18%)
|
2 |
Gastrointestinal And Abdominal Pains (Excl Oral And Throat) |
17/1257 (1.35%)
|
19 |
4/367 (1.09%)
|
4 |
14/1108 (1.26%)
|
15 |
Gastrointestinal Atonic And Hypomotility Disorders |
14/1257 (1.11%)
|
15 |
0/367 (0.00%)
|
0 |
6/1108 (0.54%)
|
7 |
Gastrointestinal Disorders |
1/1257 (0.08%)
|
1 |
1/367 (0.27%)
|
1 |
0/1108 (0.00%)
|
0 |
Gastrointestinal Dyskinetic Disorders |
1/1257 (0.08%)
|
1 |
1/367 (0.27%)
|
1 |
0/1108 (0.00%)
|
0 |
Gastrointestinal Fistulae |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Gastrointestinal Inflammatory Disorders |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Gastrointestinal Necrosis And Gangrene (Excl Gangrenous Hernia) |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
2/1108 (0.18%)
|
2 |
Gastrointestinal Signs And Symptoms |
35/1257 (2.78%)
|
35 |
12/367 (3.27%)
|
13 |
16/1108 (1.44%)
|
17 |
Gastrointestinal Stenosis And Obstruction |
3/1257 (0.24%)
|
3 |
2/367 (0.54%)
|
2 |
7/1108 (0.63%)
|
7 |
Gastrointestinal Ulcers And Perforation, Site Unspecified |
3/1257 (0.24%)
|
3 |
0/367 (0.00%)
|
0 |
2/1108 (0.18%)
|
2 |
Gastrointestinal Vascular Occlusion And Infarction |
3/1257 (0.24%)
|
3 |
2/367 (0.54%)
|
2 |
6/1108 (0.54%)
|
6 |
Gingival Disorders |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Haemorrhoids And Gastrointestinal Varices (Excl Oesophageal) |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
4/1108 (0.36%)
|
4 |
Inguinal Hernias |
5/1257 (0.40%)
|
6 |
2/367 (0.54%)
|
2 |
5/1108 (0.45%)
|
5 |
Intestinal Haemorrhages |
9/1257 (0.72%)
|
10 |
3/367 (0.82%)
|
3 |
9/1108 (0.81%)
|
9 |
Intestinal Ulcers And Perforation |
2/1257 (0.16%)
|
2 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
2 |
Large Intestinal Stenosis And Obstruction |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Nausea And Vomiting Symptoms |
11/1257 (0.88%)
|
11 |
6/367 (1.63%)
|
8 |
12/1108 (1.08%)
|
12 |
Non-Site Specific Gastrointestinal Haemorrhages |
98/1257 (7.80%)
|
121 |
26/367 (7.08%)
|
35 |
71/1108 (6.41%)
|
84 |
Oesophageal Disorders |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Oesophageal Stenosis And Obstruction |
6/1257 (0.48%)
|
6 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
2 |
Oesophageal Ulcers And Perforation |
1/1257 (0.08%)
|
1 |
1/367 (0.27%)
|
1 |
0/1108 (0.00%)
|
0 |
Oesophagitis (Excl Infective) |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Peritoneal And Retroperitoneal Disorders |
5/1257 (0.40%)
|
5 |
2/367 (0.54%)
|
2 |
4/1108 (0.36%)
|
4 |
Peritoneal And Retroperitoneal Haemorrhages |
5/1257 (0.40%)
|
5 |
1/367 (0.27%)
|
1 |
9/1108 (0.81%)
|
9 |
Tongue Disorders |
0/1257 (0.00%)
|
0 |
1/367 (0.27%)
|
1 |
0/1108 (0.00%)
|
0 |
Umbilical Hernias |
1/1257 (0.08%)
|
1 |
2/367 (0.54%)
|
2 |
0/1108 (0.00%)
|
0 |
General disorders |
|
|
|
Administration Site Reactions |
2/1257 (0.16%)
|
2 |
0/367 (0.00%)
|
0 |
2/1108 (0.18%)
|
2 |
Asthenic Conditions |
31/1257 (2.47%)
|
33 |
8/367 (2.18%)
|
10 |
23/1108 (2.08%)
|
25 |
Body Temperature Altered |
2/1257 (0.16%)
|
2 |
1/367 (0.27%)
|
1 |
1/1108 (0.09%)
|
1 |
Complications Associated With Device |
5/1257 (0.40%)
|
5 |
1/367 (0.27%)
|
1 |
7/1108 (0.63%)
|
9 |
Death And Sudden Death |
49/1257 (3.90%)
|
49 |
18/367 (4.90%)
|
18 |
38/1108 (3.43%)
|
38 |
Device Issues |
130/1257 (10.34%)
|
140 |
17/367 (4.63%)
|
19 |
93/1108 (8.39%)
|
103 |
Device Malfunction Events |
7/1257 (0.56%)
|
7 |
2/367 (0.54%)
|
2 |
7/1108 (0.63%)
|
7 |
Device Physical Property And Chemical Issues |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Febrile Disorders |
24/1257 (1.91%)
|
24 |
5/367 (1.36%)
|
5 |
15/1108 (1.35%)
|
15 |
Gait Disturbances |
3/1257 (0.24%)
|
3 |
0/367 (0.00%)
|
0 |
2/1108 (0.18%)
|
2 |
General Signs And Symptoms |
20/1257 (1.59%)
|
20 |
4/367 (1.09%)
|
4 |
11/1108 (0.99%)
|
11 |
Healing Abnormal |
4/1257 (0.32%)
|
4 |
1/367 (0.27%)
|
1 |
1/1108 (0.09%)
|
1 |
Hernias |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
2/1108 (0.18%)
|
2 |
Implant And Catheter Site Reactions |
4/1257 (0.32%)
|
5 |
1/367 (0.27%)
|
2 |
9/1108 (0.81%)
|
9 |
Inflammations |
2/1257 (0.16%)
|
2 |
0/367 (0.00%)
|
0 |
5/1108 (0.45%)
|
5 |
Injection Site Reactions |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Mucosal Findings Abnormal |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Oedema |
31/1257 (2.47%)
|
32 |
7/367 (1.91%)
|
8 |
15/1108 (1.35%)
|
17 |
Pain And Discomfort |
67/1257 (5.33%)
|
85 |
14/367 (3.81%)
|
18 |
40/1108 (3.61%)
|
41 |
Product Physical Issues |
6/1257 (0.48%)
|
6 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Therapeutic And Nontherapeutic Responses |
1/1257 (0.08%)
|
1 |
1/367 (0.27%)
|
1 |
3/1108 (0.27%)
|
3 |
Ulcers |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
2/1108 (0.18%)
|
2 |
Vascular Complications Associated With Device |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Hepatobiliary disorders |
|
|
|
Bile Duct Infections And Inflammations |
2/1257 (0.16%)
|
2 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Cholecystitis And Cholelithiasis |
11/1257 (0.88%)
|
11 |
4/367 (1.09%)
|
4 |
7/1108 (0.63%)
|
7 |
Cholestasis And Jaundice |
0/1257 (0.00%)
|
0 |
1/367 (0.27%)
|
1 |
1/1108 (0.09%)
|
1 |
Gallbladder Disorders |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Hepatic And Hepatobiliary Disorders |
1/1257 (0.08%)
|
1 |
2/367 (0.54%)
|
2 |
1/1108 (0.09%)
|
1 |
Hepatic Failure And Associated Disorders |
7/1257 (0.56%)
|
7 |
0/367 (0.00%)
|
0 |
5/1108 (0.45%)
|
5 |
Hepatic Fibrosis And Cirrhosis |
4/1257 (0.32%)
|
4 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Hepatic Vascular Disorders |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Hepatobiliary Signs And Symptoms |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Hepatocellular Damage And Hepatitis |
4/1257 (0.32%)
|
4 |
1/367 (0.27%)
|
1 |
5/1108 (0.45%)
|
5 |
Obstructive Bile Duct Disorders (Excl Neoplasms) |
4/1257 (0.32%)
|
4 |
3/367 (0.82%)
|
3 |
1/1108 (0.09%)
|
1 |
Immune system disorders |
|
|
|
Acute And Chronic Sarcoidosis |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Allergic Conditions |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
2/1108 (0.18%)
|
2 |
Allergies To Foods, Food Additives, Drugs And Other Chemicals |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Infections and infestations |
|
|
|
Abdominal And Gastrointestinal Infections |
14/1257 (1.11%)
|
14 |
2/367 (0.54%)
|
2 |
9/1108 (0.81%)
|
9 |
Aspergillus Infections |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Atypical Mycobacterial Infections |
0/1257 (0.00%)
|
0 |
1/367 (0.27%)
|
1 |
1/1108 (0.09%)
|
1 |
Bacterial Infections |
54/1257 (4.30%)
|
66 |
17/367 (4.63%)
|
22 |
37/1108 (3.34%)
|
42 |
Bone And Joint Infections |
11/1257 (0.88%)
|
12 |
2/367 (0.54%)
|
2 |
7/1108 (0.63%)
|
7 |
Candida Infections |
1/1257 (0.08%)
|
1 |
2/367 (0.54%)
|
2 |
1/1108 (0.09%)
|
1 |
Cardiac Infections |
15/1257 (1.19%)
|
16 |
5/367 (1.36%)
|
5 |
10/1108 (0.90%)
|
10 |
Clostridia Infections |
19/1257 (1.51%)
|
23 |
9/367 (2.45%)
|
12 |
11/1108 (0.99%)
|
13 |
Dental And Oral Soft Tissue Infections |
2/1257 (0.16%)
|
2 |
1/367 (0.27%)
|
1 |
3/1108 (0.27%)
|
5 |
Ear Infections |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Enterobacter Infections |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Enterococcal Infections |
2/1257 (0.16%)
|
2 |
1/367 (0.27%)
|
1 |
3/1108 (0.27%)
|
4 |
Escherichia Infections |
3/1257 (0.24%)
|
3 |
0/367 (0.00%)
|
0 |
2/1108 (0.18%)
|
2 |
Eye And Eyelid Infections |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Fungal Infections |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Haemophilus Infections |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Helicobacter Infections |
2/1257 (0.16%)
|
2 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Hepatobiliary And Spleen Infections |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Herpes Viral Infections |
4/1257 (0.32%)
|
4 |
0/367 (0.00%)
|
0 |
5/1108 (0.45%)
|
5 |
Infections |
28/1257 (2.23%)
|
30 |
8/367 (2.18%)
|
8 |
20/1108 (1.81%)
|
22 |
Infectious Disorders Carrier |
1/1257 (0.08%)
|
1 |
1/367 (0.27%)
|
1 |
0/1108 (0.00%)
|
0 |
Infectious Transmissions |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Influenza Viral Infections |
14/1257 (1.11%)
|
14 |
2/367 (0.54%)
|
2 |
11/1108 (0.99%)
|
12 |
Klebsiella Infections |
0/1257 (0.00%)
|
0 |
2/367 (0.54%)
|
2 |
3/1108 (0.27%)
|
3 |
Lower Respiratory Tract And Lung Infections |
170/1257 (13.52%)
|
218 |
61/367 (16.62%)
|
73 |
101/1108 (9.12%)
|
116 |
Male Reproductive Tract Infections |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
2 |
Pseudomonal Infections |
2/1257 (0.16%)
|
2 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Respiratory Syncytial Viral Infections |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Salmonella Infections |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Sepsis, Bacteraemia, Viraemia And Fungaemia |
113/1257 (8.99%)
|
133 |
35/367 (9.54%)
|
37 |
82/1108 (7.40%)
|
87 |
Skin Structures And Soft Tissue Infections |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
2/1108 (0.18%)
|
2 |
Staphylococcal Infections |
15/1257 (1.19%)
|
17 |
4/367 (1.09%)
|
5 |
8/1108 (0.72%)
|
8 |
Streptococcal Infections |
1/1257 (0.08%)
|
1 |
2/367 (0.54%)
|
2 |
5/1108 (0.45%)
|
5 |
Upper Respiratory Tract Infections |
8/1257 (0.64%)
|
8 |
0/367 (0.00%)
|
0 |
7/1108 (0.63%)
|
7 |
Urinary Tract Infections |
112/1257 (8.91%)
|
132 |
25/367 (6.81%)
|
32 |
58/1108 (5.23%)
|
67 |
Vascular Infections |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Viral Infections |
6/1257 (0.48%)
|
6 |
3/367 (0.82%)
|
3 |
2/1108 (0.18%)
|
2 |
Injury, poisoning and procedural complications |
|
|
|
Abdominal Injuries |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
2/1108 (0.18%)
|
2 |
Cardiac And Vascular Procedural Complications |
37/1257 (2.94%)
|
38 |
7/367 (1.91%)
|
7 |
27/1108 (2.44%)
|
27 |
Cardiovascular Injuries |
9/1257 (0.72%)
|
9 |
3/367 (0.82%)
|
3 |
3/1108 (0.27%)
|
3 |
Cerebral Injuries |
16/1257 (1.27%)
|
17 |
4/367 (1.09%)
|
5 |
11/1108 (0.99%)
|
13 |
Chest And Lung Injuries |
3/1257 (0.24%)
|
3 |
0/367 (0.00%)
|
0 |
2/1108 (0.18%)
|
2 |
Ear Injuries |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Eye Injuries |
3/1257 (0.24%)
|
3 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Fractures And Dislocations |
7/1257 (0.56%)
|
8 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Gastrointestinal And Hepatobiliary Procedural Complications |
1/1257 (0.08%)
|
1 |
2/367 (0.54%)
|
2 |
0/1108 (0.00%)
|
0 |
Limb Injuries (Incl Traumatic Amputation) |
3/1257 (0.24%)
|
3 |
1/367 (0.27%)
|
1 |
5/1108 (0.45%)
|
5 |
Lower Limb Fractures And Dislocations |
69/1257 (5.49%)
|
73 |
9/367 (2.45%)
|
9 |
28/1108 (2.53%)
|
28 |
Muscle, Tendon And Ligament Injuries |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Nerve Injuries |
0/1257 (0.00%)
|
0 |
1/367 (0.27%)
|
1 |
0/1108 (0.00%)
|
0 |
Neurological And Psychiatric Procedural Complications |
1/1257 (0.08%)
|
1 |
1/367 (0.27%)
|
1 |
0/1108 (0.00%)
|
0 |
Non-Site Specific Injuries |
63/1257 (5.01%)
|
67 |
16/367 (4.36%)
|
16 |
48/1108 (4.33%)
|
51 |
Non-Site Specific Procedural Complications |
78/1257 (6.21%)
|
82 |
25/367 (6.81%)
|
29 |
52/1108 (4.69%)
|
54 |
Overdoses |
1/1257 (0.08%)
|
1 |
1/367 (0.27%)
|
1 |
1/1108 (0.09%)
|
1 |
Pelvic Fractures And Dislocations |
9/1257 (0.72%)
|
9 |
0/367 (0.00%)
|
0 |
4/1108 (0.36%)
|
4 |
Poisoning And Toxicity |
4/1257 (0.32%)
|
4 |
3/367 (0.82%)
|
3 |
5/1108 (0.45%)
|
5 |
Renal And Urinary Tract Injuries |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
2/1108 (0.18%)
|
2 |
Respiratory Tract And Thoracic Cavity Procedural Complications |
1/1257 (0.08%)
|
1 |
1/367 (0.27%)
|
1 |
2/1108 (0.18%)
|
2 |
Site Specific Injuries |
8/1257 (0.64%)
|
8 |
1/367 (0.27%)
|
1 |
5/1108 (0.45%)
|
5 |
Skin Injuries |
21/1257 (1.67%)
|
24 |
6/367 (1.63%)
|
8 |
12/1108 (1.08%)
|
13 |
Skull Fractures, Facial Bone Fractures And Dislocations |
1/1257 (0.08%)
|
1 |
1/367 (0.27%)
|
1 |
2/1108 (0.18%)
|
2 |
Spinal Fractures And Dislocations |
18/1257 (1.43%)
|
18 |
1/367 (0.27%)
|
1 |
7/1108 (0.63%)
|
9 |
Thermal Burns |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Thoracic Cage Fractures And Dislocations |
5/1257 (0.40%)
|
5 |
1/367 (0.27%)
|
1 |
3/1108 (0.27%)
|
3 |
Transfusion Related Complications |
2/1257 (0.16%)
|
2 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Upper Limb Fractures And Dislocations |
11/1257 (0.88%)
|
13 |
3/367 (0.82%)
|
3 |
12/1108 (1.08%)
|
14 |
Urinary Tract Procedural Complications |
0/1257 (0.00%)
|
0 |
1/367 (0.27%)
|
1 |
0/1108 (0.00%)
|
0 |
Investigations |
|
|
|
Blood Counts |
7/1257 (0.56%)
|
7 |
0/367 (0.00%)
|
0 |
4/1108 (0.36%)
|
4 |
Blood Gas And Acid Base Analyses |
6/1257 (0.48%)
|
6 |
7/367 (1.91%)
|
7 |
1/1108 (0.09%)
|
1 |
Carbohydrate Tolerance Analyses (Incl Diabetes) |
1/1257 (0.08%)
|
1 |
1/367 (0.27%)
|
1 |
7/1108 (0.63%)
|
7 |
Cardiac Function Diagnostic Procedures |
16/1257 (1.27%)
|
16 |
4/367 (1.09%)
|
4 |
17/1108 (1.53%)
|
17 |
Coagulation And Bleeding Analyses |
22/1257 (1.75%)
|
22 |
6/367 (1.63%)
|
6 |
14/1108 (1.26%)
|
17 |
Ecg Investigations |
3/1257 (0.24%)
|
3 |
3/367 (0.82%)
|
3 |
1/1108 (0.09%)
|
1 |
Faecal Analyses |
2/1257 (0.16%)
|
2 |
1/367 (0.27%)
|
1 |
1/1108 (0.09%)
|
1 |
Heart Rate And Pulse Investigations |
4/1257 (0.32%)
|
4 |
0/367 (0.00%)
|
0 |
2/1108 (0.18%)
|
2 |
Hepatobiliary Histopathology Procedures |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Liver Function Analyses |
2/1257 (0.16%)
|
2 |
2/367 (0.54%)
|
2 |
1/1108 (0.09%)
|
1 |
Metabolism Tests |
0/1257 (0.00%)
|
0 |
1/367 (0.27%)
|
1 |
1/1108 (0.09%)
|
1 |
Mineral And Electrolyte Analyses |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
3/1108 (0.27%)
|
4 |
Musculoskeletal And Soft Tissue Histopathology Procedures |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Physical Examination Procedures |
3/1257 (0.24%)
|
3 |
2/367 (0.54%)
|
2 |
0/1108 (0.00%)
|
0 |
Platelet Analyses |
3/1257 (0.24%)
|
3 |
1/367 (0.27%)
|
1 |
0/1108 (0.00%)
|
0 |
Protein Analyses |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Red Blood Cell Analyses |
11/1257 (0.88%)
|
12 |
5/367 (1.36%)
|
5 |
8/1108 (0.72%)
|
9 |
Renal Function Analyses |
10/1257 (0.80%)
|
10 |
1/367 (0.27%)
|
1 |
5/1108 (0.45%)
|
5 |
Respiratory And Pulmonary Function Diagnostic Procedures |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Respiratory Tract And Thoracic Imaging Procedures |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Skeletal And Cardiac Muscle Analyses |
9/1257 (0.72%)
|
10 |
3/367 (0.82%)
|
3 |
5/1108 (0.45%)
|
5 |
Urinalysis |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
2/1108 (0.18%)
|
2 |
Urinary Tract Function Analyses |
5/1257 (0.40%)
|
5 |
2/367 (0.54%)
|
2 |
5/1108 (0.45%)
|
5 |
Vascular Auscultatory Investigations |
3/1257 (0.24%)
|
3 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Vascular Tests (Incl Blood Pressure) |
8/1257 (0.64%)
|
9 |
1/367 (0.27%)
|
1 |
2/1108 (0.18%)
|
2 |
White Blood Cell Analyses |
4/1257 (0.32%)
|
4 |
0/367 (0.00%)
|
0 |
2/1108 (0.18%)
|
2 |
Metabolism and nutrition disorders |
|
|
|
Appetite Disorders |
3/1257 (0.24%)
|
3 |
1/367 (0.27%)
|
1 |
0/1108 (0.00%)
|
0 |
Calcium Metabolism Disorders |
1/1257 (0.08%)
|
3 |
2/367 (0.54%)
|
2 |
3/1108 (0.27%)
|
3 |
Chloride Imbalance |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Diabetes Mellitus (Incl Subtypes) |
4/1257 (0.32%)
|
4 |
2/367 (0.54%)
|
3 |
4/1108 (0.36%)
|
4 |
Diabetic Complications |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Disorders Of Purine Metabolism |
6/1257 (0.48%)
|
7 |
0/367 (0.00%)
|
0 |
8/1108 (0.72%)
|
9 |
Electrolyte Imbalance |
12/1257 (0.95%)
|
12 |
3/367 (0.82%)
|
3 |
4/1108 (0.36%)
|
4 |
General Nutritional Disorders |
31/1257 (2.47%)
|
32 |
12/367 (3.27%)
|
12 |
10/1108 (0.90%)
|
10 |
Hyperglycaemic Conditions |
18/1257 (1.43%)
|
20 |
8/367 (2.18%)
|
8 |
15/1108 (1.35%)
|
15 |
Hypoglycaemic Conditions |
13/1257 (1.03%)
|
13 |
9/367 (2.45%)
|
10 |
8/1108 (0.72%)
|
8 |
Magnesium Metabolism Disorders |
0/1257 (0.00%)
|
0 |
3/367 (0.82%)
|
3 |
2/1108 (0.18%)
|
2 |
Metabolic Acidoses (Excl Diabetic Acidoses) |
6/1257 (0.48%)
|
6 |
2/367 (0.54%)
|
2 |
4/1108 (0.36%)
|
4 |
Metabolic Alkaloses |
0/1257 (0.00%)
|
0 |
1/367 (0.27%)
|
1 |
2/1108 (0.18%)
|
2 |
Mixed Acid-Base Disorders |
1/1257 (0.08%)
|
1 |
1/367 (0.27%)
|
1 |
3/1108 (0.27%)
|
3 |
Phosphorus Metabolism Disorders |
2/1257 (0.16%)
|
2 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Potassium Imbalance |
34/1257 (2.70%)
|
37 |
10/367 (2.72%)
|
12 |
25/1108 (2.26%)
|
26 |
Protein Metabolism Disorders |
2/1257 (0.16%)
|
2 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Sodium Imbalance |
21/1257 (1.67%)
|
23 |
2/367 (0.54%)
|
2 |
20/1108 (1.81%)
|
23 |
Total Fluid Volume Decreased |
37/1257 (2.94%)
|
37 |
13/367 (3.54%)
|
14 |
29/1108 (2.62%)
|
30 |
Total Fluid Volume Increased |
35/1257 (2.78%)
|
36 |
10/367 (2.72%)
|
10 |
23/1108 (2.08%)
|
23 |
Musculoskeletal and connective tissue disorders |
|
|
|
Arthropathies |
3/1257 (0.24%)
|
3 |
0/367 (0.00%)
|
0 |
3/1108 (0.27%)
|
3 |
Bone Disorders |
2/1257 (0.16%)
|
2 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Bursal Disorders |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Connective Tissue Disorders (Excl Le) |
2/1257 (0.16%)
|
2 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Crystal Arthropathic Disorders |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Extremity Deformities |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Joint Related Disorders |
2/1257 (0.16%)
|
3 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Joint Related Signs And Symptoms |
10/1257 (0.80%)
|
10 |
3/367 (0.82%)
|
3 |
9/1108 (0.81%)
|
9 |
Muscle Infections And Inflammations |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Muscle Pains |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Muscle Related Signs And Symptoms |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Muscle Weakness Conditions |
8/1257 (0.64%)
|
8 |
4/367 (1.09%)
|
4 |
5/1108 (0.45%)
|
5 |
Musculoskeletal And Connective Tissue Pain And Discomfort |
38/1257 (3.02%)
|
43 |
8/367 (2.18%)
|
8 |
23/1108 (2.08%)
|
25 |
Musculoskeletal And Connective Tissue Signs And Symptoms |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
2/1108 (0.18%)
|
2 |
Myopathies |
3/1257 (0.24%)
|
3 |
2/367 (0.54%)
|
2 |
3/1108 (0.27%)
|
3 |
Osteoarthropathies |
6/1257 (0.48%)
|
8 |
1/367 (0.27%)
|
1 |
13/1108 (1.17%)
|
15 |
Rheumatoid Arthropathies |
1/1257 (0.08%)
|
2 |
1/367 (0.27%)
|
1 |
0/1108 (0.00%)
|
0 |
Soft Tissue Disorders |
2/1257 (0.16%)
|
2 |
0/367 (0.00%)
|
0 |
3/1108 (0.27%)
|
3 |
Spine And Neck Deformities |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
2/1108 (0.18%)
|
2 |
Tendon Disorders |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
B-Cell Lymphomas |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Bile Duct Neoplasms Malignant |
0/1257 (0.00%)
|
0 |
1/367 (0.27%)
|
1 |
0/1108 (0.00%)
|
0 |
Bladder Neoplasms Malignant |
5/1257 (0.40%)
|
5 |
1/367 (0.27%)
|
1 |
1/1108 (0.09%)
|
1 |
Bone Neoplasms Malignant (Excl Sarcomas) |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Breast And Nipple Neoplasms Malignant |
5/1257 (0.40%)
|
5 |
0/367 (0.00%)
|
0 |
2/1108 (0.18%)
|
2 |
Burkitt's Lymphomas |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Cardiovascular Neoplasms Benign |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Central Nervous System Neoplasms Malignant |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
2/1108 (0.18%)
|
2 |
Colonic Neoplasms Malignant |
6/1257 (0.48%)
|
6 |
0/367 (0.00%)
|
0 |
4/1108 (0.36%)
|
4 |
Hepatic Neoplasms Malignant |
1/1257 (0.08%)
|
1 |
1/367 (0.27%)
|
1 |
0/1108 (0.00%)
|
0 |
Leiomyosarcomas |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Leukaemias Acute Myeloid |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Leukaemias Chronic Lymphocytic |
1/1257 (0.08%)
|
1 |
1/367 (0.27%)
|
1 |
2/1108 (0.18%)
|
2 |
Leukaemias |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
2/1108 (0.18%)
|
2 |
Lip And Oral Cavity Neoplasms Malignant |
2/1257 (0.16%)
|
2 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Lymphomas Unspecified |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Mantle Cell Lymphomas |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Metastases To Specified Sites |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
2/1108 (0.18%)
|
2 |
Multiple Myelomas |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Myelodysplastic Syndromes |
0/1257 (0.00%)
|
0 |
2/367 (0.54%)
|
3 |
4/1108 (0.36%)
|
4 |
Myeloproliferative Disorders (Excl Leukaemias) |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Neoplasms Malignant Site Unspecified |
9/1257 (0.72%)
|
9 |
3/367 (0.82%)
|
3 |
6/1108 (0.54%)
|
6 |
Nervous System Neoplasms Unspecified Malignancy |
1/1257 (0.08%)
|
1 |
1/367 (0.27%)
|
1 |
1/1108 (0.09%)
|
1 |
Non-Small Cell Neoplasms Malignant Of The Respiratory Tract Cell Type Specified |
0/1257 (0.00%)
|
0 |
2/367 (0.54%)
|
2 |
0/1108 (0.00%)
|
0 |
Oesophageal Neoplasms Malignant |
1/1257 (0.08%)
|
1 |
1/367 (0.27%)
|
1 |
1/1108 (0.09%)
|
1 |
Oncologic Complications And Emergencies |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Pancreatic Neoplasms Malignant (Excl Islet Cell And Carcinoid) |
0/1257 (0.00%)
|
0 |
2/367 (0.54%)
|
2 |
3/1108 (0.27%)
|
3 |
Prostatic Neoplasms Malignant |
4/1257 (0.32%)
|
4 |
1/367 (0.27%)
|
1 |
2/1108 (0.18%)
|
2 |
Rectal Neoplasms Malignant |
2/1257 (0.16%)
|
2 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Renal Neoplasms Malignant |
2/1257 (0.16%)
|
2 |
1/367 (0.27%)
|
1 |
2/1108 (0.18%)
|
2 |
Respiratory Tract And Pleural Neoplasms Malignant Cell Type Unspecified |
6/1257 (0.48%)
|
7 |
7/367 (1.91%)
|
7 |
2/1108 (0.18%)
|
2 |
Skin Melanomas (Excl Ocular) |
1/1257 (0.08%)
|
1 |
1/367 (0.27%)
|
1 |
0/1108 (0.00%)
|
0 |
Skin Neoplasms Benign |
1/1257 (0.08%)
|
2 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Skin Neoplasms Malignant And Unspecified (Excl Melanoma) |
6/1257 (0.48%)
|
6 |
0/367 (0.00%)
|
0 |
3/1108 (0.27%)
|
3 |
Small Intestinal Neoplasms Malignant |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Soft Tissue Sarcomas Histology Unspecified |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Thyroid Neoplasms Malignant |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Urinary Tract Neoplasms Malignant |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Uterine Neoplasms Benign |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Uterine Neoplasms Malignant |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Vulval Neoplasms Malignant |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Nervous system disorders |
|
|
|
Acute Polyneuropathies |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Alzheimer's Disease (Incl Subtypes) |
1/1257 (0.08%)
|
1 |
2/367 (0.54%)
|
2 |
0/1108 (0.00%)
|
0 |
Autonomic Nervous System Disorders |
1/1257 (0.08%)
|
2 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Central Nervous System Aneurysms |
1/1257 (0.08%)
|
1 |
1/367 (0.27%)
|
1 |
1/1108 (0.09%)
|
1 |
Central Nervous System Haemorrhages And Cerebrovascular Accidents |
98/1257 (7.80%)
|
105 |
30/367 (8.17%)
|
33 |
79/1108 (7.13%)
|
86 |
Central Nervous System Vascular Disorders |
10/1257 (0.80%)
|
11 |
2/367 (0.54%)
|
3 |
7/1108 (0.63%)
|
7 |
Cerebellar Coordination And Balance Disturbances |
3/1257 (0.24%)
|
3 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Coma States |
0/1257 (0.00%)
|
0 |
1/367 (0.27%)
|
1 |
1/1108 (0.09%)
|
1 |
Cortical Dysfunction |
1/1257 (0.08%)
|
1 |
1/367 (0.27%)
|
1 |
1/1108 (0.09%)
|
1 |
Dementia (Excl Alzheimer's Type) |
5/1257 (0.40%)
|
5 |
0/367 (0.00%)
|
0 |
5/1108 (0.45%)
|
5 |
Disturbances In Consciousness |
42/1257 (3.34%)
|
46 |
13/367 (3.54%)
|
14 |
32/1108 (2.89%)
|
33 |
Dyskinesias And Movement Disorders |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Encephalopathies |
27/1257 (2.15%)
|
29 |
8/367 (2.18%)
|
8 |
13/1108 (1.17%)
|
13 |
Encephalopathies Toxic And Metabolic |
22/1257 (1.75%)
|
22 |
1/367 (0.27%)
|
1 |
14/1108 (1.26%)
|
14 |
Facial Cranial Nerve Disorders |
2/1257 (0.16%)
|
2 |
0/367 (0.00%)
|
0 |
2/1108 (0.18%)
|
2 |
Generalised Tonic-Clonic Seizures |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Headaches |
10/1257 (0.80%)
|
10 |
1/367 (0.27%)
|
1 |
8/1108 (0.72%)
|
9 |
Hydrocephalic Conditions |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Lumbar Spinal Cord And Nerve Root Disorders |
2/1257 (0.16%)
|
2 |
1/367 (0.27%)
|
1 |
1/1108 (0.09%)
|
1 |
Memory Loss (Excl Dementia) |
2/1257 (0.16%)
|
2 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Mental Impairment (Excl Dementia And Memory Loss) |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Mononeuropathies |
2/1257 (0.16%)
|
2 |
2/367 (0.54%)
|
2 |
0/1108 (0.00%)
|
0 |
Motor Neurone Diseases |
0/1257 (0.00%)
|
0 |
1/367 (0.27%)
|
1 |
0/1108 (0.00%)
|
0 |
Multiple Sclerosis Acute And Progressive |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Myelitis (Incl Infective) |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Nervous System Disorders |
0/1257 (0.00%)
|
0 |
1/367 (0.27%)
|
1 |
0/1108 (0.00%)
|
0 |
Neurological Signs And Symptoms |
32/1257 (2.55%)
|
34 |
6/367 (1.63%)
|
6 |
18/1108 (1.62%)
|
19 |
Neuromuscular Junction Dysfunction |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Paralysis And Paresis (Excl Cranial Nerve) |
1/1257 (0.08%)
|
1 |
1/367 (0.27%)
|
1 |
4/1108 (0.36%)
|
4 |
Parkinson's Disease And Parkinsonism |
3/1257 (0.24%)
|
4 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Peripheral Neuropathies |
2/1257 (0.16%)
|
2 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Seizures And Seizure Disorders |
12/1257 (0.95%)
|
18 |
3/367 (0.82%)
|
3 |
5/1108 (0.45%)
|
5 |
Sensory Abnormalities |
3/1257 (0.24%)
|
3 |
0/367 (0.00%)
|
0 |
5/1108 (0.45%)
|
5 |
Speech And Language Abnormalities |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Spinal Cord And Nerve Root Disorders |
1/1257 (0.08%)
|
1 |
1/367 (0.27%)
|
1 |
1/1108 (0.09%)
|
1 |
Structural Brain Disorders |
3/1257 (0.24%)
|
3 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Transient Cerebrovascular Events |
30/1257 (2.39%)
|
34 |
5/367 (1.36%)
|
6 |
24/1108 (2.17%)
|
27 |
Tremor (Excl Congenital) |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
2/1108 (0.18%)
|
2 |
Trigeminal Disorders |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Vagus Nerve Disorders |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Psychiatric disorders |
|
|
|
Abnormal Behaviour |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Anxiety Disorders |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Anxiety Symptoms |
8/1257 (0.64%)
|
10 |
4/367 (1.09%)
|
4 |
10/1108 (0.90%)
|
11 |
Behaviour And Socialisation Disturbances |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Bipolar Disorders |
0/1257 (0.00%)
|
0 |
1/367 (0.27%)
|
1 |
0/1108 (0.00%)
|
0 |
Confusion And Disorientation |
24/1257 (1.91%)
|
24 |
10/367 (2.72%)
|
10 |
20/1108 (1.81%)
|
20 |
Deliria |
14/1257 (1.11%)
|
14 |
1/367 (0.27%)
|
1 |
9/1108 (0.81%)
|
9 |
Delusional Symptoms |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
2/1108 (0.18%)
|
2 |
Depressive Disorders |
6/1257 (0.48%)
|
6 |
1/367 (0.27%)
|
1 |
4/1108 (0.36%)
|
4 |
Disturbances In Initiating And Maintaining Sleep |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
2/1108 (0.18%)
|
2 |
Eating Disorders |
0/1257 (0.00%)
|
0 |
2/367 (0.54%)
|
2 |
0/1108 (0.00%)
|
0 |
Mental Disorders |
56/1257 (4.46%)
|
64 |
19/367 (5.18%)
|
21 |
29/1108 (2.62%)
|
29 |
Panic Attacks And Disorders |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
2/1108 (0.18%)
|
2 |
Perception Disturbances |
2/1257 (0.16%)
|
2 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Psychiatric Symptoms |
0/1257 (0.00%)
|
0 |
1/367 (0.27%)
|
1 |
0/1108 (0.00%)
|
0 |
Psychotic Disorder |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
2/1108 (0.18%)
|
2 |
Speech Articulation And Rhythm Disturbances |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Stress Disorders |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Substance-Related Disorders |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Suicidal And Self-Injurious Behaviour |
3/1257 (0.24%)
|
3 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Renal and urinary disorders |
|
|
|
Bladder And Urethral Symptoms |
51/1257 (4.06%)
|
57 |
6/367 (1.63%)
|
8 |
48/1108 (4.33%)
|
49 |
Bladder Disorders |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
4/1108 (0.36%)
|
4 |
Genital And Urinary Tract Disorders |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Myoneurogenic Bladder Disorders |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Nephropathies And Tubular Disorders |
3/1257 (0.24%)
|
3 |
0/367 (0.00%)
|
0 |
2/1108 (0.18%)
|
2 |
Renal Disorders |
0/1257 (0.00%)
|
0 |
1/367 (0.27%)
|
1 |
1/1108 (0.09%)
|
1 |
Renal Failure And Impairment |
208/1257 (16.55%)
|
263 |
76/367 (20.71%)
|
94 |
154/1108 (13.90%)
|
181 |
Renal Failure Complications |
2/1257 (0.16%)
|
2 |
1/367 (0.27%)
|
1 |
1/1108 (0.09%)
|
1 |
Renal Lithiasis |
2/1257 (0.16%)
|
2 |
0/367 (0.00%)
|
0 |
6/1108 (0.54%)
|
7 |
Renal Neoplasms |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Renal Obstructive Disorders |
4/1257 (0.32%)
|
4 |
1/367 (0.27%)
|
1 |
0/1108 (0.00%)
|
0 |
Renal Vascular And Ischaemic Conditions |
2/1257 (0.16%)
|
2 |
1/367 (0.27%)
|
1 |
4/1108 (0.36%)
|
4 |
Structural And Obstructive Urethral Disorders (Excl Congenital) |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
3/1108 (0.27%)
|
3 |
Ureteric Disorders |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Urinary Abnormalities |
29/1257 (2.31%)
|
33 |
9/367 (2.45%)
|
9 |
29/1108 (2.62%)
|
36 |
Urinary Tract Lithiasis (Excl Renal) |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
2/1108 (0.18%)
|
2 |
Reproductive system and breast disorders |
|
|
|
Breast Disorders |
2/1257 (0.16%)
|
2 |
1/367 (0.27%)
|
1 |
0/1108 (0.00%)
|
0 |
Cervix Disorders |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Ovarian And Fallopian Tube Cysts And Neoplasms |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Pelvis And Broad Ligament Disorders |
0/1257 (0.00%)
|
0 |
1/367 (0.27%)
|
1 |
1/1108 (0.09%)
|
1 |
Penile And Scrotal Infections And Inflammations |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Penile Disorders (Excl Erection And Ejaculation) |
2/1257 (0.16%)
|
2 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Prostatic Neoplasms And Hypertrophy |
4/1257 (0.32%)
|
4 |
1/367 (0.27%)
|
1 |
2/1108 (0.18%)
|
2 |
Prostatic Signs, Symptoms And Disorders |
2/1257 (0.16%)
|
2 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Reproductive Tract Signs And Symptoms |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Scrotal Disorders |
3/1257 (0.24%)
|
3 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Testicular And Epididymal Disorders |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Vulvovaginal Disorders |
1/1257 (0.08%)
|
1 |
1/367 (0.27%)
|
1 |
0/1108 (0.00%)
|
0 |
Vulvovaginal Signs And Symptoms |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Respiratory, thoracic and mediastinal disorders |
|
|
|
Breathing Abnormalities |
101/1257 (8.04%)
|
121 |
31/367 (8.45%)
|
39 |
66/1108 (5.96%)
|
76 |
Bronchial Conditions |
3/1257 (0.24%)
|
3 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
2 |
Bronchospasm And Obstruction |
55/1257 (4.38%)
|
94 |
26/367 (7.08%)
|
40 |
35/1108 (3.16%)
|
42 |
Conditions Associated With Abnormal Gas Exchange |
25/1257 (1.99%)
|
26 |
11/367 (3.00%)
|
12 |
22/1108 (1.99%)
|
23 |
Coughing And Associated Symptoms |
18/1257 (1.43%)
|
20 |
6/367 (1.63%)
|
7 |
6/1108 (0.54%)
|
6 |
Diaphragmatic Disorders |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Laryngeal And Adjacent Sites Disorders (Excl Infections And Neoplasms) |
2/1257 (0.16%)
|
2 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Laryngeal Spasm, Oedema And Obstruction |
2/1257 (0.16%)
|
2 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Lower Respiratory Tract Inflammatory And Immunologic Conditions |
34/1257 (2.70%)
|
37 |
6/367 (1.63%)
|
7 |
14/1108 (1.26%)
|
15 |
Lower Respiratory Tract Signs And Symptoms |
4/1257 (0.32%)
|
4 |
1/367 (0.27%)
|
1 |
1/1108 (0.09%)
|
1 |
Mediastinal Disorders |
2/1257 (0.16%)
|
2 |
6/367 (1.63%)
|
6 |
1/1108 (0.09%)
|
1 |
Nasal Disorders |
17/1257 (1.35%)
|
20 |
11/367 (3.00%)
|
12 |
14/1108 (1.26%)
|
15 |
Parenchymal Lung Disorders |
13/1257 (1.03%)
|
14 |
4/367 (1.09%)
|
4 |
10/1108 (0.90%)
|
10 |
Pharyngeal Disorders (Excl Infections And Neoplasms) |
3/1257 (0.24%)
|
3 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Pleural Conditions |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Pneumothorax And Pleural Effusions |
106/1257 (8.43%)
|
137 |
70/367 (19.07%)
|
91 |
75/1108 (6.77%)
|
92 |
Pulmonary Hypertensions |
7/1257 (0.56%)
|
7 |
3/367 (0.82%)
|
3 |
8/1108 (0.72%)
|
9 |
Pulmonary Oedemas |
31/1257 (2.47%)
|
34 |
17/367 (4.63%)
|
17 |
35/1108 (3.16%)
|
40 |
Pulmonary Thrombotic And Embolic Conditions |
9/1257 (0.72%)
|
9 |
4/367 (1.09%)
|
5 |
11/1108 (0.99%)
|
11 |
Respiratory Failures (Excl Neonatal) |
149/1257 (11.85%)
|
192 |
66/367 (17.98%)
|
77 |
108/1108 (9.75%)
|
126 |
Respiratory Tract Disorders |
4/1257 (0.32%)
|
4 |
3/367 (0.82%)
|
3 |
1/1108 (0.09%)
|
1 |
Upper Respiratory Tract Signs And Symptoms |
0/1257 (0.00%)
|
0 |
1/367 (0.27%)
|
1 |
1/1108 (0.09%)
|
1 |
Skin and subcutaneous tissue disorders |
|
|
|
Bullous Conditions |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Dermal And Epidermal Conditions |
7/1257 (0.56%)
|
7 |
2/367 (0.54%)
|
2 |
2/1108 (0.18%)
|
2 |
Dermatitis And Eczema |
0/1257 (0.00%)
|
0 |
2/367 (0.54%)
|
2 |
0/1108 (0.00%)
|
0 |
Erythemas |
2/1257 (0.16%)
|
2 |
0/367 (0.00%)
|
0 |
2/1108 (0.18%)
|
2 |
Exfoliative Conditions |
0/1257 (0.00%)
|
0 |
1/367 (0.27%)
|
1 |
0/1108 (0.00%)
|
0 |
Hyperkeratoses |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Nail And Nail Bed Conditions (Excl Infections And Infestations) |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Pruritus |
0/1257 (0.00%)
|
0 |
1/367 (0.27%)
|
1 |
1/1108 (0.09%)
|
1 |
Purpura And Related Conditions |
2/1257 (0.16%)
|
2 |
1/367 (0.27%)
|
1 |
0/1108 (0.00%)
|
0 |
Rashes, Eruptions And Exanthems |
2/1257 (0.16%)
|
2 |
1/367 (0.27%)
|
1 |
3/1108 (0.27%)
|
3 |
Skin And Subcutaneous Conditions |
0/1257 (0.00%)
|
0 |
1/367 (0.27%)
|
1 |
0/1108 (0.00%)
|
0 |
Skin And Subcutaneous Tissue Ulcerations |
9/1257 (0.72%)
|
10 |
2/367 (0.54%)
|
2 |
7/1108 (0.63%)
|
7 |
Skin Injuries And Mechanical Dermatoses |
5/1257 (0.40%)
|
5 |
3/367 (0.82%)
|
3 |
1/1108 (0.09%)
|
1 |
Skin Preneoplastic Conditions |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Skin Vasculitides |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Skin Vasomotor Conditions |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Surgical and medical procedures |
|
|
|
Arterial Therapeutic Procedures (Excl Aortic) |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Cardiac Device Therapeutic Procedures |
8/1257 (0.64%)
|
8 |
2/367 (0.54%)
|
2 |
3/1108 (0.27%)
|
3 |
Haematological Therapeutic Procedures |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Joint Therapeutic Procedures |
5/1257 (0.40%)
|
5 |
1/367 (0.27%)
|
1 |
1/1108 (0.09%)
|
1 |
Large Intestine Therapeutic Procedures |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
2/1108 (0.18%)
|
2 |
Lens Therapeutic Procedures |
2/1257 (0.16%)
|
2 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Prostatic Therapeutic Procedures |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Renal Therapeutic Procedures |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Therapeutic Bladder Catheterisation |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Therapeutic Procedures |
20/1257 (1.59%)
|
22 |
1/367 (0.27%)
|
1 |
11/1108 (0.99%)
|
11 |
Tracheal Therapeutic Procedures |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Venous Therapeutic Procedures |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Vascular disorders |
|
|
|
Accelerated And Malignant Hypertension |
13/1257 (1.03%)
|
13 |
2/367 (0.54%)
|
2 |
13/1108 (1.17%)
|
13 |
Aneurysms And Dissections Non-Site Specific |
5/1257 (0.40%)
|
5 |
2/367 (0.54%)
|
2 |
6/1108 (0.54%)
|
6 |
Aortic Aneurysms And Dissections |
8/1257 (0.64%)
|
9 |
6/367 (1.63%)
|
6 |
5/1108 (0.45%)
|
5 |
Aortic Embolism And Thrombosis |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Aortic Necrosis And Vascular Insufficiency |
3/1257 (0.24%)
|
3 |
1/367 (0.27%)
|
1 |
1/1108 (0.09%)
|
1 |
Arterial And Aortic Injuries |
11/1257 (0.88%)
|
11 |
0/367 (0.00%)
|
0 |
10/1108 (0.90%)
|
11 |
Arterial Inflammations |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
0/1108 (0.00%)
|
0 |
Blood Pressure Disorders |
4/1257 (0.32%)
|
4 |
1/367 (0.27%)
|
1 |
3/1108 (0.27%)
|
3 |
Circulatory Collapse And Shock |
7/1257 (0.56%)
|
7 |
4/367 (1.09%)
|
4 |
4/1108 (0.36%)
|
4 |
Haemorrhages |
43/1257 (3.42%)
|
43 |
16/367 (4.36%)
|
16 |
33/1108 (2.98%)
|
34 |
Lymphangiopathies |
1/1257 (0.08%)
|
1 |
1/367 (0.27%)
|
1 |
2/1108 (0.18%)
|
2 |
Lymphoedemas |
2/1257 (0.16%)
|
2 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Non-Site Specific Embolism And Thrombosis |
9/1257 (0.72%)
|
10 |
4/367 (1.09%)
|
4 |
7/1108 (0.63%)
|
7 |
Non-Site Specific Necrosis And Vascular Insufficiency |
6/1257 (0.48%)
|
6 |
1/367 (0.27%)
|
1 |
4/1108 (0.36%)
|
5 |
Non-Site Specific Vascular Disorders |
16/1257 (1.27%)
|
16 |
10/367 (2.72%)
|
10 |
12/1108 (1.08%)
|
12 |
Peripheral Aneurysms And Dissections |
24/1257 (1.91%)
|
24 |
2/367 (0.54%)
|
2 |
11/1108 (0.99%)
|
11 |
Peripheral Embolism And Thrombosis |
20/1257 (1.59%)
|
20 |
8/367 (2.18%)
|
8 |
17/1108 (1.53%)
|
19 |
Peripheral Vascular Disorders |
5/1257 (0.40%)
|
6 |
5/367 (1.36%)
|
8 |
6/1108 (0.54%)
|
6 |
Peripheral Vasoconstriction, Necrosis And Vascular Insufficiency |
35/1257 (2.78%)
|
37 |
16/367 (4.36%)
|
17 |
41/1108 (3.70%)
|
44 |
Phlebitis |
0/1257 (0.00%)
|
0 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Site Specific Necrosis And Vascular Insufficiency |
1/1257 (0.08%)
|
1 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Site Specific Vascular Disorders |
3/1257 (0.24%)
|
3 |
1/367 (0.27%)
|
1 |
1/1108 (0.09%)
|
2 |
Vascular Hypertensive Disorders |
54/1257 (4.30%)
|
60 |
22/367 (5.99%)
|
23 |
53/1108 (4.78%)
|
57 |
Vascular Hypotensive Disorders |
137/1257 (10.90%)
|
157 |
50/367 (13.62%)
|
52 |
90/1108 (8.12%)
|
93 |
Vascular Malformations And Acquired Anomalies |
2/1257 (0.16%)
|
2 |
0/367 (0.00%)
|
0 |
1/1108 (0.09%)
|
1 |
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA 14.1
|
|
Frequency Threshold for Reporting Other Adverse Events
|
5%
|
|
Extreme Risk: TAVI Iliofemoral
|
Extreme Risk: TAVI Non-Iliofemoral
|
High Risk: TAVI
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
1097/1257 (87.27%)
|
|
327/367 (89.10%)
|
|
1001/1108 (90.34%)
|
|
Blood and lymphatic system disorders |
|
|
|
Anaemias |
244/1257 (19.41%)
|
259 |
92/367 (25.07%)
|
96 |
260/1108 (23.47%)
|
267 |
Leukocytoses |
82/1257 (6.52%)
|
88 |
38/367 (10.35%)
|
40 |
79/1108 (7.13%)
|
81 |