Time Frame |
Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
|
Adverse Event Reporting Description |
All new or worsening AEs were collected through12 months.
|
|
Arm/Group Title
|
Extreme Risk: TAVI Iliofemoral
|
Extreme Risk: TAVI Non-Iliofemoral
|
High Risk: TAVI
|
High Risk: SAVR
|
Arm/Group Description |
Extreme Risk Patients: Medtronic Co...
|
Extreme Risk Patients: Medtronic Co...
|
High Risk Surgical Patients: Medtro...
|
High Risk Surgical Patients: Surgic...
|
Arm/Group Description |
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
|
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
|
High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
|
High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
|
|
|
Extreme Risk: TAVI Iliofemoral
|
Extreme Risk: TAVI Non-Iliofemoral
|
High Risk: TAVI
|
High Risk: SAVR
|
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Total |
--/--
|
|
--/--
|
|
--/--
|
|
--/--
|
|
|
|
Extreme Risk: TAVI Iliofemoral
|
Extreme Risk: TAVI Non-Iliofemoral
|
High Risk: TAVI
|
High Risk: SAVR
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
452/489 (92.43%)
|
|
142/150 (94.67%)
|
|
346/390 (88.72%)
|
|
324/357 (90.76%)
|
|
Blood and lymphatic system disorders |
|
|
|
|
Anaemia Deficiencies |
2/489 (0.41%)
|
2 |
0/150 (0.00%)
|
0 |
2/390 (0.51%)
|
2 |
0/357 (0.00%)
|
0 |
Anaemias Due To Chronic Disorders |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Anaemias Haemolytic Immune |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Anaemias Nec |
140/489 (28.63%)
|
170 |
70/150 (46.67%)
|
75 |
106/390 (27.18%)
|
132 |
151/357 (42.30%)
|
173 |
Coagulopathies |
2/489 (0.41%)
|
3 |
2/150 (1.33%)
|
2 |
1/390 (0.26%)
|
1 |
4/357 (1.12%)
|
4 |
Eosinophilic Disorders |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Haematological Disorders |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Leukocytoses Nec |
5/489 (1.02%)
|
5 |
1/150 (0.67%)
|
1 |
3/390 (0.77%)
|
3 |
4/357 (1.12%)
|
4 |
Marrow Depression And Hypoplastic Anaemias |
1/489 (0.20%)
|
1 |
1/150 (0.67%)
|
1 |
2/390 (0.51%)
|
2 |
1/357 (0.28%)
|
1 |
Thrombocytopenias |
11/489 (2.25%)
|
11 |
4/150 (2.67%)
|
4 |
8/390 (2.05%)
|
8 |
22/357 (6.16%)
|
22 |
Cardiac disorders |
|
|
|
|
Aortic Valvular Disorders |
44/489 (9.00%)
|
45 |
12/150 (8.00%)
|
12 |
42/390 (10.77%)
|
42 |
10/357 (2.80%)
|
12 |
Cardiac Conduction Disorders |
106/489 (21.68%)
|
109 |
24/150 (16.00%)
|
27 |
79/390 (20.26%)
|
85 |
18/357 (5.04%)
|
19 |
Cardiac Disorders Nec |
9/489 (1.84%)
|
9 |
3/150 (2.00%)
|
3 |
7/390 (1.79%)
|
9 |
7/357 (1.96%)
|
7 |
Cardiac Signs And Symptoms Nec |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
4/357 (1.12%)
|
4 |
Cardiac Valve Disorders Nec |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Cardiomyopathies |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
4/390 (1.03%)
|
4 |
1/357 (0.28%)
|
1 |
Coronary Artery Disorders Nec |
6/489 (1.23%)
|
6 |
4/150 (2.67%)
|
4 |
9/390 (2.31%)
|
9 |
4/357 (1.12%)
|
4 |
Heart Failures Nec |
117/489 (23.93%)
|
186 |
29/150 (19.33%)
|
43 |
69/390 (17.69%)
|
95 |
62/357 (17.37%)
|
85 |
Ischaemic Coronary Artery Disorders |
28/489 (5.73%)
|
30 |
8/150 (5.33%)
|
8 |
15/390 (3.85%)
|
17 |
12/357 (3.36%)
|
15 |
Mitral Valvular Disorders |
9/489 (1.84%)
|
9 |
5/150 (3.33%)
|
5 |
3/390 (0.77%)
|
3 |
5/357 (1.40%)
|
5 |
Myocardial Disorders Nec |
2/489 (0.41%)
|
2 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
2/357 (0.56%)
|
2 |
Noninfectious Pericarditis |
0/489 (0.00%)
|
0 |
1/150 (0.67%)
|
1 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Pericardial Disorders Nec |
5/489 (1.02%)
|
7 |
4/150 (2.67%)
|
4 |
5/390 (1.28%)
|
5 |
10/357 (2.80%)
|
10 |
Rate And Rhythm Disorders Nec |
28/489 (5.73%)
|
29 |
6/150 (4.00%)
|
6 |
16/390 (4.10%)
|
18 |
19/357 (5.32%)
|
19 |
Right Ventricular Failures |
3/489 (0.61%)
|
4 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
1/357 (0.28%)
|
1 |
Supraventricular Arrhythmias |
65/489 (13.29%)
|
79 |
17/150 (11.33%)
|
22 |
43/390 (11.03%)
|
46 |
69/357 (19.33%)
|
80 |
Tricuspid Valvular Disorders |
2/489 (0.41%)
|
2 |
3/150 (2.00%)
|
3 |
0/390 (0.00%)
|
0 |
2/357 (0.56%)
|
2 |
Ventricular Arrhythmias And Cardiac Arrest |
48/489 (9.82%)
|
59 |
26/150 (17.33%)
|
30 |
27/390 (6.92%)
|
29 |
27/357 (7.56%)
|
27 |
Congenital, familial and genetic disorders |
|
|
|
|
Cardiac Septal Defects Congenital |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Coagulation Disorders Congenital |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Male Reproductive Tract Disorders Congenital |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Vascular Anomalies Congenital Nec |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Ear and labyrinth disorders |
|
|
|
|
Hearing Losses |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Ear Disorders Nec |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Inner Ear Signs And Symptoms |
0/489 (0.00%)
|
0 |
1/150 (0.67%)
|
1 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Endocrine disorders |
|
|
|
|
Thyroid Neoplasms |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Eye disorders |
|
|
|
|
Blindness (Excl Colour Blindness) |
1/489 (0.20%)
|
1 |
1/150 (0.67%)
|
1 |
2/390 (0.51%)
|
2 |
0/357 (0.00%)
|
0 |
Cataract Conditions |
2/489 (0.41%)
|
2 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
1/357 (0.28%)
|
1 |
Corneal Infections, Oedemas And Inflammations |
0/489 (0.00%)
|
0 |
1/150 (0.67%)
|
1 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Lacrimal Disorders |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Retinal Bleeding And Vascular Disorders (Excl Retinopathy) |
2/489 (0.41%)
|
2 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
1/357 (0.28%)
|
1 |
Retinal Structural Change, Deposit And Degeneration |
1/489 (0.20%)
|
2 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Retinal, Choroid And Vitreous Infections And Inflammations |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Visual Disorders Nec |
2/489 (0.41%)
|
2 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
1/357 (0.28%)
|
1 |
Gastrointestinal disorders |
|
|
|
|
Abdominal Wall Conditions Nec |
1/489 (0.20%)
|
2 |
1/150 (0.67%)
|
1 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Acute And Chronic Pancreatitis |
4/489 (0.82%)
|
4 |
0/150 (0.00%)
|
0 |
2/390 (0.51%)
|
2 |
1/357 (0.28%)
|
1 |
Anal And Rectal Ulcers And Perforation |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Benign Neoplasms Gastrointestinal (Excl Oral Cavity) |
0/489 (0.00%)
|
0 |
1/150 (0.67%)
|
1 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Colitis (Excl Infective) |
2/489 (0.41%)
|
2 |
2/150 (1.33%)
|
2 |
0/390 (0.00%)
|
0 |
4/357 (1.12%)
|
4 |
Diaphragmatic Hernias |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Diarrhoea (Excl Infective) |
4/489 (0.82%)
|
4 |
3/150 (2.00%)
|
3 |
3/390 (0.77%)
|
3 |
2/357 (0.56%)
|
2 |
Diverticula |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
2/357 (0.56%)
|
2 |
Duodenal And Small Intestinal Stenosis And Obstruction |
2/489 (0.41%)
|
2 |
3/150 (2.00%)
|
3 |
2/390 (0.51%)
|
2 |
3/357 (0.84%)
|
3 |
Duodenal Ulcers And Perforation |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
2/390 (0.51%)
|
2 |
1/357 (0.28%)
|
1 |
Dyspeptic Signs And Symptoms |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Faecal Abnormalities Nec |
0/489 (0.00%)
|
0 |
1/150 (0.67%)
|
1 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Flatulence, Bloating And Distension |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
1/357 (0.28%)
|
1 |
Gastric And Oesophageal Haemorrhages |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Gastric Ulcers And Perforation |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
3/357 (0.84%)
|
3 |
Gastritis (Excl Infective) |
3/489 (0.61%)
|
3 |
1/150 (0.67%)
|
1 |
2/390 (0.51%)
|
2 |
2/357 (0.56%)
|
2 |
Gastrointestinal And Abdominal Pains (Excl Oral And Throat) |
13/489 (2.66%)
|
15 |
4/150 (2.67%)
|
4 |
3/390 (0.77%)
|
3 |
2/357 (0.56%)
|
2 |
Gastrointestinal Atonic And Hypomotility Disorders Nec |
3/489 (0.61%)
|
3 |
1/150 (0.67%)
|
1 |
3/390 (0.77%)
|
4 |
1/357 (0.28%)
|
1 |
Gastrointestinal Fistulae |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Gastrointestinal Necrosis And Gangrene (Excl Gangrenous Hernia) |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Gastrointestinal Disorders Nec |
2/489 (0.41%)
|
2 |
1/150 (0.67%)
|
1 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Gastrointestinal Signs And Symptoms Nec |
15/489 (3.07%)
|
15 |
7/150 (4.67%)
|
7 |
7/390 (1.79%)
|
7 |
12/357 (3.36%)
|
13 |
Gastrointestinal Spastic And Hypermotility Disorders |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Gastrointestinal Stenosis And Obstruction Nec |
5/489 (1.02%)
|
5 |
1/150 (0.67%)
|
1 |
3/390 (0.77%)
|
3 |
3/357 (0.84%)
|
3 |
Gastrointestinal Ulcers And Perforation, Site Unspecified |
1/489 (0.20%)
|
1 |
1/150 (0.67%)
|
1 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Gastrointestinal Vascular Occlusion And Infarction |
3/489 (0.61%)
|
3 |
1/150 (0.67%)
|
1 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Haemorrhoids And Gastrointestinal Varices (Excl Oesophageal) |
0/489 (0.00%)
|
0 |
1/150 (0.67%)
|
1 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Inguinal Hernias |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Intestinal Haemorrhages |
4/489 (0.82%)
|
4 |
1/150 (0.67%)
|
1 |
5/390 (1.28%)
|
5 |
4/357 (1.12%)
|
4 |
Intestinal Ulcers And Perforation Nec |
3/489 (0.61%)
|
3 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Nausea And Vomiting Symptoms |
2/489 (0.41%)
|
2 |
1/150 (0.67%)
|
2 |
3/390 (0.77%)
|
5 |
5/357 (1.40%)
|
5 |
Non-Site Specific Gastrointestinal Haemorrhages |
35/489 (7.16%)
|
40 |
18/150 (12.00%)
|
20 |
27/390 (6.92%)
|
29 |
16/357 (4.48%)
|
17 |
Oesophageal Stenosis And Obstruction |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Oesophageal Ulcers And Perforation |
2/489 (0.41%)
|
2 |
0/150 (0.00%)
|
0 |
3/390 (0.77%)
|
3 |
1/357 (0.28%)
|
1 |
Oesophagitis (Excl Infective) |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Oral Soft Tissue Pain And Paraesthesia |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Pancreatic Neoplasms |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Peritoneal And Retroperitoneal Disorders |
1/489 (0.20%)
|
2 |
2/150 (1.33%)
|
2 |
0/390 (0.00%)
|
0 |
2/357 (0.56%)
|
2 |
Peritoneal And Retroperitoneal Haemorrhages |
5/489 (1.02%)
|
5 |
1/150 (0.67%)
|
1 |
2/390 (0.51%)
|
2 |
1/357 (0.28%)
|
1 |
Umbilical Hernias |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Hepatic Fibrosis And Cirrhosis |
3/489 (0.61%)
|
3 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Clostridia Infections |
9/489 (1.84%)
|
9 |
2/150 (1.33%)
|
2 |
6/390 (1.54%)
|
7 |
6/357 (1.68%)
|
6 |
General disorders |
|
|
|
|
Administration Site Reactions Nec |
1/489 (0.20%)
|
1 |
1/150 (0.67%)
|
1 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Asthenic Conditions |
11/489 (2.25%)
|
12 |
3/150 (2.00%)
|
3 |
9/390 (2.31%)
|
10 |
9/357 (2.52%)
|
9 |
Body Temperature Altered |
2/489 (0.41%)
|
2 |
1/150 (0.67%)
|
1 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Cardiac Complications Associated With Device |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Complications Associated With Device Nec |
4/489 (0.82%)
|
4 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Death And Sudden Death |
10/489 (2.04%)
|
10 |
5/150 (3.33%)
|
5 |
6/390 (1.54%)
|
6 |
3/357 (0.84%)
|
3 |
Device Issues Nec |
40/489 (8.18%)
|
40 |
7/150 (4.67%)
|
7 |
28/390 (7.18%)
|
30 |
2/357 (0.56%)
|
2 |
Device Malfunction Events Nec |
1/489 (0.20%)
|
1 |
1/150 (0.67%)
|
1 |
5/390 (1.28%)
|
5 |
5/357 (1.40%)
|
5 |
Febrile Disorders |
3/489 (0.61%)
|
3 |
2/150 (1.33%)
|
2 |
7/390 (1.79%)
|
7 |
6/357 (1.68%)
|
6 |
Feelings And Sensations Nec |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Gait Disturbances |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
3/390 (0.77%)
|
3 |
0/357 (0.00%)
|
0 |
General Signs And Symptoms Nec |
7/489 (1.43%)
|
7 |
2/150 (1.33%)
|
2 |
4/390 (1.03%)
|
4 |
5/357 (1.40%)
|
5 |
Healing Abnormal Nec |
2/489 (0.41%)
|
2 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Hernias Nec |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Implant And Catheter Site Reactions |
3/489 (0.61%)
|
3 |
0/150 (0.00%)
|
0 |
2/390 (0.51%)
|
2 |
0/357 (0.00%)
|
0 |
Inflammations |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Injection Site Reactions |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Mass Conditions Nec |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Oedema Nec |
6/489 (1.23%)
|
7 |
1/150 (0.67%)
|
1 |
6/390 (1.54%)
|
7 |
6/357 (1.68%)
|
6 |
Pain And Discomfort Nec |
26/489 (5.32%)
|
33 |
9/150 (6.00%)
|
11 |
23/390 (5.90%)
|
29 |
19/357 (5.32%)
|
22 |
Product Physical Issues |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
2/390 (0.51%)
|
2 |
0/357 (0.00%)
|
0 |
Therapeutic And Nontherapeutic Responses |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Withdrawal And Rebound Effects |
0/489 (0.00%)
|
0 |
1/150 (0.67%)
|
1 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Hepatobiliary disorders |
|
|
|
|
Bile Duct Infections And Inflammations |
1/489 (0.20%)
|
1 |
1/150 (0.67%)
|
1 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Cholecystitis And Cholelithiasis |
3/489 (0.61%)
|
3 |
1/150 (0.67%)
|
1 |
4/390 (1.03%)
|
4 |
1/357 (0.28%)
|
1 |
Hepatic And Hepatobiliary Disorders Nec |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Hepatic Failure And Associated Disorders |
3/489 (0.61%)
|
3 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
3/357 (0.84%)
|
3 |
Hepatocellular Damage And Hepatitis Nec |
5/489 (1.02%)
|
5 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
2/357 (0.56%)
|
2 |
Immune system disorders |
|
|
|
|
Anaphylactic Responses |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Infections and infestations |
|
|
|
|
Abdominal And Gastrointestinal Infections |
6/489 (1.23%)
|
8 |
1/150 (0.67%)
|
1 |
4/390 (1.03%)
|
4 |
4/357 (1.12%)
|
4 |
Atypical Mycobacterial Infections |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Bacterial Infections Nec |
22/489 (4.50%)
|
25 |
6/150 (4.00%)
|
6 |
15/390 (3.85%)
|
20 |
12/357 (3.36%)
|
12 |
Bone And Joint Infections |
1/489 (0.20%)
|
1 |
1/150 (0.67%)
|
1 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Candida Infections |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Cardiac Infections |
6/489 (1.23%)
|
7 |
1/150 (0.67%)
|
1 |
1/390 (0.26%)
|
1 |
3/357 (0.84%)
|
3 |
Central Nervous System And Spinal Infections |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Ear Infections |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Enterobacter Infections |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
2/357 (0.56%)
|
2 |
Enterococcal Infections |
4/489 (0.82%)
|
5 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
2/357 (0.56%)
|
2 |
Escherichia Infections |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Fungal Infections Nec |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
1/357 (0.28%)
|
1 |
Haemophilus Infections |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Herpes Viral Infections |
0/489 (0.00%)
|
0 |
2/150 (1.33%)
|
2 |
2/390 (0.51%)
|
2 |
0/357 (0.00%)
|
0 |
Infections Nec |
8/489 (1.64%)
|
8 |
2/150 (1.33%)
|
2 |
6/390 (1.54%)
|
6 |
8/357 (2.24%)
|
8 |
Infectious Transmissions |
0/489 (0.00%)
|
0 |
1/150 (0.67%)
|
1 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Influenza Viral Infections |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Klebsiella Infections |
1/489 (0.20%)
|
1 |
1/150 (0.67%)
|
1 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Lower Respiratory Tract And Lung Infections |
74/489 (15.13%)
|
95 |
25/150 (16.67%)
|
26 |
44/390 (11.28%)
|
48 |
36/357 (10.08%)
|
43 |
Pseudomonal Infections |
1/489 (0.20%)
|
2 |
1/150 (0.67%)
|
1 |
1/390 (0.26%)
|
1 |
2/357 (0.56%)
|
2 |
Sepsis, Bacteraemia, Viraemia And Fungaemia Nec |
32/489 (6.54%)
|
35 |
17/150 (11.33%)
|
18 |
32/390 (8.21%)
|
38 |
29/357 (8.12%)
|
36 |
Staphylococcal Infections |
3/489 (0.61%)
|
3 |
4/150 (2.67%)
|
4 |
3/390 (0.77%)
|
3 |
3/357 (0.84%)
|
4 |
Streptococcal Infections |
2/489 (0.41%)
|
2 |
3/150 (2.00%)
|
3 |
2/390 (0.51%)
|
2 |
0/357 (0.00%)
|
0 |
Upper Respiratory Tract Infections |
1/489 (0.20%)
|
1 |
2/150 (1.33%)
|
2 |
2/390 (0.51%)
|
2 |
0/357 (0.00%)
|
0 |
Urinary Tract Infections |
28/489 (5.73%)
|
32 |
9/150 (6.00%)
|
11 |
21/390 (5.38%)
|
21 |
20/357 (5.60%)
|
22 |
Vascular Infections |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Viral Infections Nec |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Injury, poisoning and procedural complications |
|
|
|
|
Anaesthetic Complications |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Cardiac And Vascular Procedural Complications |
16/489 (3.27%)
|
17 |
3/150 (2.00%)
|
4 |
7/390 (1.79%)
|
7 |
3/357 (0.84%)
|
3 |
Cardiovascular Injuries |
3/489 (0.61%)
|
3 |
2/150 (1.33%)
|
2 |
0/390 (0.00%)
|
0 |
2/357 (0.56%)
|
2 |
Cerebral Injuries Nec |
0/489 (0.00%)
|
0 |
2/150 (1.33%)
|
2 |
5/390 (1.28%)
|
5 |
2/357 (0.56%)
|
2 |
Chest And Lung Injuries Nec |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
1/357 (0.28%)
|
1 |
Fractures And Dislocations Nec |
0/489 (0.00%)
|
0 |
2/150 (1.33%)
|
3 |
1/390 (0.26%)
|
1 |
3/357 (0.84%)
|
3 |
Gastrointestinal And Hepatobiliary Procedural Complications |
1/489 (0.20%)
|
1 |
1/150 (0.67%)
|
1 |
0/390 (0.00%)
|
0 |
2/357 (0.56%)
|
2 |
Limb Injuries Nec (Incl Traumatic Amputation) |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Lower Limb Fractures And Dislocations |
18/489 (3.68%)
|
19 |
1/150 (0.67%)
|
1 |
9/390 (2.31%)
|
10 |
10/357 (2.80%)
|
12 |
Non-Site Specific Injuries Nec |
13/489 (2.66%)
|
13 |
4/150 (2.67%)
|
4 |
14/390 (3.59%)
|
16 |
6/357 (1.68%)
|
6 |
Non-Site Specific Procedural Complications |
25/489 (5.11%)
|
27 |
6/150 (4.00%)
|
6 |
25/390 (6.41%)
|
26 |
28/357 (7.84%)
|
29 |
Pelvic Fractures And Dislocations |
4/489 (0.82%)
|
4 |
2/150 (1.33%)
|
2 |
2/390 (0.51%)
|
2 |
1/357 (0.28%)
|
1 |
Poisoning And Toxicity |
2/489 (0.41%)
|
2 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Radiation Injuries |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Reproductive System And Breast Injuries |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Respiratory Tract And Thoracic Cavity Procedural Complications |
0/489 (0.00%)
|
0 |
1/150 (0.67%)
|
1 |
0/390 (0.00%)
|
0 |
3/357 (0.84%)
|
3 |
Site Specific Injuries Nec |
1/489 (0.20%)
|
1 |
1/150 (0.67%)
|
1 |
3/390 (0.77%)
|
3 |
1/357 (0.28%)
|
1 |
Skin Injuries Nec |
10/489 (2.04%)
|
11 |
1/150 (0.67%)
|
1 |
5/390 (1.28%)
|
5 |
5/357 (1.40%)
|
5 |
Skin Procedural Complications |
0/489 (0.00%)
|
0 |
1/150 (0.67%)
|
1 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Skull Fractures, Facial Bone Fractures And Dislocations |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Spinal Fractures And Dislocations |
6/489 (1.23%)
|
7 |
1/150 (0.67%)
|
1 |
5/390 (1.28%)
|
8 |
2/357 (0.56%)
|
2 |
Thoracic Cage Fractures And Dislocations |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
1/357 (0.28%)
|
1 |
Transfusion Related Complications |
0/489 (0.00%)
|
0 |
1/150 (0.67%)
|
1 |
1/390 (0.26%)
|
1 |
1/357 (0.28%)
|
1 |
Upper Limb Fractures And Dislocations |
10/489 (2.04%)
|
11 |
0/150 (0.00%)
|
0 |
2/390 (0.51%)
|
2 |
5/357 (1.40%)
|
6 |
Investigations |
|
|
|
|
Bacteria Identification And Serology (Excl Mycobacteria) |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Blood Counts Nec |
2/489 (0.41%)
|
2 |
2/150 (1.33%)
|
2 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Blood Gas And Acid Base Analyses |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
3/390 (0.77%)
|
3 |
0/357 (0.00%)
|
0 |
Carbohydrate Tolerance Analyses (Incl Diabetes) |
2/489 (0.41%)
|
2 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Cardiac Function Diagnostic Procedures |
2/489 (0.41%)
|
2 |
3/150 (2.00%)
|
3 |
0/390 (0.00%)
|
0 |
6/357 (1.68%)
|
6 |
Coagulation And Bleeding Analyses |
5/489 (1.02%)
|
5 |
2/150 (1.33%)
|
2 |
6/390 (1.54%)
|
6 |
6/357 (1.68%)
|
7 |
Ecg Investigations |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
2/390 (0.51%)
|
2 |
0/357 (0.00%)
|
0 |
Liver Function Analyses |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Metabolism Tests Nec |
0/489 (0.00%)
|
0 |
1/150 (0.67%)
|
1 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Microbiology And Serology Tests Nec |
2/489 (0.41%)
|
2 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Mineral And Electrolyte Analyses |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
1/357 (0.28%)
|
1 |
Physical Examination Procedures |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
2/390 (0.51%)
|
2 |
2/357 (0.56%)
|
2 |
Platelet Analyses |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
1/357 (0.28%)
|
1 |
Protein Analyses Nec |
0/489 (0.00%)
|
0 |
1/150 (0.67%)
|
1 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Red Blood Cell Analyses |
13/489 (2.66%)
|
13 |
4/150 (2.67%)
|
4 |
10/390 (2.56%)
|
10 |
11/357 (3.08%)
|
11 |
Renal Function Analyses |
4/489 (0.82%)
|
4 |
1/150 (0.67%)
|
1 |
2/390 (0.51%)
|
2 |
1/357 (0.28%)
|
1 |
Respiratory Tract And Thoracic Imaging Procedures |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Skeletal And Cardiac Muscle Analyses |
4/489 (0.82%)
|
4 |
2/150 (1.33%)
|
2 |
1/390 (0.26%)
|
1 |
5/357 (1.40%)
|
5 |
Tissue Enzyme Analyses Nec |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Urinalysis Nec |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Urinary Tract Function Analyses Nec |
3/489 (0.61%)
|
3 |
2/150 (1.33%)
|
2 |
0/390 (0.00%)
|
0 |
3/357 (0.84%)
|
3 |
Vascular Tests Nec (Incl Blood Pressure) |
3/489 (0.61%)
|
3 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
White Blood Cell Analyses |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Metabolism and nutrition disorders |
|
|
|
|
Appetite Disorders |
1/489 (0.20%)
|
1 |
1/150 (0.67%)
|
1 |
1/390 (0.26%)
|
1 |
2/357 (0.56%)
|
2 |
Calcium Metabolism Disorders |
2/489 (0.41%)
|
2 |
1/150 (0.67%)
|
1 |
2/390 (0.51%)
|
2 |
1/357 (0.28%)
|
2 |
Diabetes Mellitus (Incl Subtypes) |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Diabetic Complications Dermal |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Diabetic Complications Nec |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Disorders Of Purine Metabolism |
3/489 (0.61%)
|
3 |
0/150 (0.00%)
|
0 |
2/390 (0.51%)
|
2 |
0/357 (0.00%)
|
0 |
Electrolyte Imbalance Nec |
5/489 (1.02%)
|
5 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
1/357 (0.28%)
|
1 |
General Nutritional Disorders Nec |
18/489 (3.68%)
|
20 |
7/150 (4.67%)
|
7 |
4/390 (1.03%)
|
4 |
15/357 (4.20%)
|
16 |
Hyperglycaemic Conditions Nec |
4/489 (0.82%)
|
4 |
1/150 (0.67%)
|
1 |
3/390 (0.77%)
|
3 |
6/357 (1.68%)
|
6 |
Hypoglycaemic Conditions Nec |
4/489 (0.82%)
|
4 |
5/150 (3.33%)
|
5 |
3/390 (0.77%)
|
3 |
4/357 (1.12%)
|
4 |
Magnesium Metabolism Disorders |
0/489 (0.00%)
|
0 |
1/150 (0.67%)
|
1 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Metabolic Acidoses (Excl Diabetic Acidoses) |
3/489 (0.61%)
|
3 |
3/150 (2.00%)
|
4 |
1/390 (0.26%)
|
1 |
4/357 (1.12%)
|
4 |
Metabolic Alkaloses |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Mixed Acid-Base Disorders |
2/489 (0.41%)
|
2 |
0/150 (0.00%)
|
0 |
3/390 (0.77%)
|
3 |
0/357 (0.00%)
|
0 |
Potassium Imbalance |
14/489 (2.86%)
|
15 |
2/150 (1.33%)
|
2 |
8/390 (2.05%)
|
8 |
5/357 (1.40%)
|
6 |
Protein Metabolism Disorders Nec |
0/489 (0.00%)
|
0 |
1/150 (0.67%)
|
1 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Sodium Imbalance |
8/489 (1.64%)
|
10 |
2/150 (1.33%)
|
3 |
5/390 (1.28%)
|
5 |
5/357 (1.40%)
|
5 |
Total Fluid Volume Decreased |
15/489 (3.07%)
|
15 |
8/150 (5.33%)
|
8 |
8/390 (2.05%)
|
9 |
14/357 (3.92%)
|
15 |
Total Fluid Volume Increased |
12/489 (2.45%)
|
13 |
1/150 (0.67%)
|
1 |
7/390 (1.79%)
|
7 |
11/357 (3.08%)
|
12 |
Musculoskeletal and connective tissue disorders |
|
|
|
|
Arthropathies Nec |
0/489 (0.00%)
|
0 |
1/150 (0.67%)
|
1 |
2/390 (0.51%)
|
2 |
1/357 (0.28%)
|
1 |
Bone Disorders Nec |
0/489 (0.00%)
|
0 |
1/150 (0.67%)
|
1 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Bone Related Signs And Symptoms |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Joint Related Signs And Symptoms |
2/489 (0.41%)
|
2 |
1/150 (0.67%)
|
1 |
3/390 (0.77%)
|
3 |
1/357 (0.28%)
|
1 |
Metabolic Bone Disorders |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Muscle Weakness Conditions |
1/489 (0.20%)
|
1 |
3/150 (2.00%)
|
3 |
0/390 (0.00%)
|
0 |
3/357 (0.84%)
|
3 |
Musculoskeletal And Connective Tissue Pain And Discomfort |
8/489 (1.64%)
|
9 |
1/150 (0.67%)
|
1 |
13/390 (3.33%)
|
15 |
7/357 (1.96%)
|
7 |
Musculoskeletal And Connective Tissue Signs And Symptoms Nec |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Myopathies |
0/489 (0.00%)
|
0 |
1/150 (0.67%)
|
1 |
0/390 (0.00%)
|
0 |
3/357 (0.84%)
|
3 |
Osteoarthropathies |
0/489 (0.00%)
|
0 |
2/150 (1.33%)
|
3 |
3/390 (0.77%)
|
4 |
1/357 (0.28%)
|
1 |
Spine And Neck Deformities |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
|
B-Cell Lymphomas Nec |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
2/390 (0.51%)
|
2 |
0/357 (0.00%)
|
0 |
Bladder Neoplasms Malignant |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
1/357 (0.28%)
|
1 |
Breast And Nipple Neoplasms Malignant |
1/489 (0.20%)
|
1 |
1/150 (0.67%)
|
1 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Colonic Neoplasms Malignant |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
1/357 (0.28%)
|
1 |
Gastric Neoplasms Malignant |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Gastrointestinal Neoplasms Malignancy Unspecified Nec |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Hepatic Neoplasms Malignant |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
1/357 (0.28%)
|
1 |
Leukaemias Acute Myeloid |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
1/357 (0.28%)
|
1 |
Multiple Myelomas |
0/489 (0.00%)
|
0 |
1/150 (0.67%)
|
1 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Myelodysplastic Syndromes |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Neoplasms Malignant Site Unspecified Nec |
3/489 (0.61%)
|
3 |
0/150 (0.00%)
|
0 |
2/390 (0.51%)
|
2 |
2/357 (0.56%)
|
2 |
Neuromas |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Pancreatic Neoplasms Malignant (Excl Islet Cell And Carcinoid) |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
2/390 (0.51%)
|
2 |
0/357 (0.00%)
|
0 |
Pharyngeal And Laryngeal Neoplasms Benign |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Prostatic Neoplasms Malignant |
3/489 (0.61%)
|
3 |
1/150 (0.67%)
|
1 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Renal Neoplasms Malignant |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Respiratory Tract And Pleural Neoplasms Malignant Cell Type Unspecified Nec |
0/489 (0.00%)
|
0 |
2/150 (1.33%)
|
2 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Skin Neoplasms Malignant And Unspecified (Excl Melanoma) |
2/489 (0.41%)
|
2 |
1/150 (0.67%)
|
1 |
2/390 (0.51%)
|
2 |
2/357 (0.56%)
|
2 |
Thyroid Neoplasms Malignant |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Nervous system disorders |
|
|
|
|
Acute Polyneuropathies |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Central Nervous System Haemorrhages And Cerebrovascular Accidents |
28/489 (5.73%)
|
28 |
14/150 (9.33%)
|
14 |
26/390 (6.67%)
|
30 |
32/357 (8.96%)
|
35 |
Central Nervous System Vascular Disorders Nec |
2/489 (0.41%)
|
2 |
0/150 (0.00%)
|
0 |
3/390 (0.77%)
|
3 |
0/357 (0.00%)
|
0 |
Cerebellar Coordination And Balance Disturbances |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
1/357 (0.28%)
|
1 |
Coma States |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
1/357 (0.28%)
|
1 |
Cortical Dysfunction Nec |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Dementia (Excl Alzheimer's Type) |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Disturbances In Consciousness Nec |
9/489 (1.84%)
|
9 |
4/150 (2.67%)
|
5 |
14/390 (3.59%)
|
15 |
7/357 (1.96%)
|
8 |
Dyskinesias And Movement Disorders Nec |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Encephalopathies Nec |
14/489 (2.86%)
|
14 |
0/150 (0.00%)
|
0 |
4/390 (1.03%)
|
4 |
5/357 (1.40%)
|
5 |
Encephalopathies Toxic And Metabolic |
8/489 (1.64%)
|
11 |
0/150 (0.00%)
|
0 |
3/390 (0.77%)
|
3 |
2/357 (0.56%)
|
2 |
Headaches Nec |
0/489 (0.00%)
|
0 |
2/150 (1.33%)
|
2 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Hydrocephalic Conditions |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Increased Intracranial Pressure Disorders |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Lumbar Spinal Cord And Nerve Root Disorders |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
1/357 (0.28%)
|
1 |
Memory Loss (Excl Dementia) |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
1/357 (0.28%)
|
1 |
Migraine Headaches |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Mononeuropathies |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
2/357 (0.56%)
|
2 |
Nervous System Disorders Nec |
0/489 (0.00%)
|
0 |
1/150 (0.67%)
|
1 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Neurological Signs And Symptoms Nec |
7/489 (1.43%)
|
8 |
8/150 (5.33%)
|
8 |
2/390 (0.51%)
|
2 |
11/357 (3.08%)
|
11 |
Neuromuscular Junction Dysfunction |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Paralysis And Paresis (Excl Cranial Nerve) |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
2/357 (0.56%)
|
2 |
Peripheral Neuropathies Nec |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Seizures And Seizure Disorders Nec |
3/489 (0.61%)
|
3 |
3/150 (2.00%)
|
4 |
1/390 (0.26%)
|
1 |
10/357 (2.80%)
|
10 |
Sensory Abnormalities Nec |
0/489 (0.00%)
|
0 |
1/150 (0.67%)
|
1 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Speech And Language Abnormalities |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Transient Cerebrovascular Events |
7/489 (1.43%)
|
8 |
1/150 (0.67%)
|
1 |
6/390 (1.54%)
|
6 |
2/357 (0.56%)
|
2 |
Tremor (Excl Congenital) |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Vagus Nerve Disorders |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Psychiatric disorders |
|
|
|
|
Anxiety Symptoms |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
2/390 (0.51%)
|
2 |
0/357 (0.00%)
|
0 |
Behaviour And Socialisation Disturbances |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Confusion And Disorientation |
6/489 (1.23%)
|
6 |
1/150 (0.67%)
|
1 |
8/390 (2.05%)
|
9 |
4/357 (1.12%)
|
4 |
Deliria |
3/489 (0.61%)
|
3 |
1/150 (0.67%)
|
1 |
4/390 (1.03%)
|
4 |
1/357 (0.28%)
|
1 |
Depressive Disorders |
3/489 (0.61%)
|
3 |
0/150 (0.00%)
|
0 |
2/390 (0.51%)
|
2 |
2/357 (0.56%)
|
2 |
Mental Disorders Nec |
13/489 (2.66%)
|
13 |
3/150 (2.00%)
|
4 |
4/390 (1.03%)
|
4 |
14/357 (3.92%)
|
14 |
Perception Disturbances |
0/489 (0.00%)
|
0 |
1/150 (0.67%)
|
1 |
2/390 (0.51%)
|
2 |
0/357 (0.00%)
|
0 |
Suicidal And Self-Injurious Behaviour |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Renal and urinary disorders |
|
|
|
|
Bladder And Urethral Symptoms |
7/489 (1.43%)
|
7 |
8/150 (5.33%)
|
9 |
8/390 (2.05%)
|
9 |
9/357 (2.52%)
|
11 |
Bladder Disorders Nec |
1/489 (0.20%)
|
1 |
3/150 (2.00%)
|
3 |
0/390 (0.00%)
|
0 |
2/357 (0.56%)
|
2 |
Genital And Urinary Tract Disorders Nec |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Nephritis Nec |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Nephropathies And Tubular Disorders Nec |
1/489 (0.20%)
|
1 |
1/150 (0.67%)
|
1 |
1/390 (0.26%)
|
1 |
1/357 (0.28%)
|
1 |
Renal Disorders Nec |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
1/357 (0.28%)
|
1 |
Renal Failure And Impairment |
90/489 (18.40%)
|
108 |
31/150 (20.67%)
|
43 |
38/390 (9.74%)
|
42 |
58/357 (16.25%)
|
66 |
Renal Failure Complications |
0/489 (0.00%)
|
0 |
1/150 (0.67%)
|
1 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Renal Lithiasis |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Renal Obstructive Disorders |
0/489 (0.00%)
|
0 |
1/150 (0.67%)
|
1 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Renal Vascular And Ischaemic Conditions |
2/489 (0.41%)
|
2 |
1/150 (0.67%)
|
1 |
1/390 (0.26%)
|
1 |
2/357 (0.56%)
|
2 |
Ureteric Disorders Nec |
0/489 (0.00%)
|
0 |
1/150 (0.67%)
|
1 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Urinary Abnormalities |
10/489 (2.04%)
|
13 |
1/150 (0.67%)
|
1 |
8/390 (2.05%)
|
8 |
6/357 (1.68%)
|
11 |
Reproductive system and breast disorders |
|
|
|
|
Breast Disorders Nec |
0/489 (0.00%)
|
0 |
1/150 (0.67%)
|
1 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Pelvic Prolapse Conditions |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Prostatic Neoplasms And Hypertrophy |
1/489 (0.20%)
|
1 |
1/150 (0.67%)
|
1 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Reproductive Tract Disorders Nec (Excl Neoplasms) |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Scrotal Disorders Nec |
2/489 (0.41%)
|
2 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Vulvovaginal Disorders Nec |
0/489 (0.00%)
|
0 |
1/150 (0.67%)
|
1 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Respiratory, thoracic and mediastinal disorders |
|
|
|
|
Breathing Abnormalities |
26/489 (5.32%)
|
27 |
21/150 (14.00%)
|
29 |
30/390 (7.69%)
|
33 |
26/357 (7.28%)
|
31 |
Bronchial Conditions Nec |
1/489 (0.20%)
|
1 |
1/150 (0.67%)
|
1 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Bronchospasm And Obstruction |
25/489 (5.11%)
|
28 |
16/150 (10.67%)
|
21 |
13/390 (3.33%)
|
15 |
8/357 (2.24%)
|
9 |
Conditions Associated With Abnormal Gas Exchange |
7/489 (1.43%)
|
7 |
1/150 (0.67%)
|
1 |
6/390 (1.54%)
|
6 |
6/357 (1.68%)
|
6 |
Coughing And Associated Symptoms |
2/489 (0.41%)
|
2 |
1/150 (0.67%)
|
1 |
5/390 (1.28%)
|
6 |
0/357 (0.00%)
|
0 |
Diaphragmatic Disorders |
0/489 (0.00%)
|
0 |
2/150 (1.33%)
|
2 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Laryngeal And Adjacent Sites Disorders Nec (Excl Infections And Neoplasms) |
0/489 (0.00%)
|
0 |
1/150 (0.67%)
|
1 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Laryngeal Spasm, Oedema And Obstruction |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Lower Respiratory Tract Inflammatory And Immunologic Conditions |
8/489 (1.64%)
|
9 |
6/150 (4.00%)
|
6 |
7/390 (1.79%)
|
7 |
8/357 (2.24%)
|
8 |
Lower Respiratory Tract Signs And Symptoms |
2/489 (0.41%)
|
2 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Mediastinal Disorders |
0/489 (0.00%)
|
0 |
2/150 (1.33%)
|
2 |
1/390 (0.26%)
|
1 |
3/357 (0.84%)
|
3 |
Nasal Disorders Nec |
4/489 (0.82%)
|
5 |
1/150 (0.67%)
|
1 |
5/390 (1.28%)
|
5 |
1/357 (0.28%)
|
1 |
Parenchymal Lung Disorders Nec |
6/489 (1.23%)
|
6 |
3/150 (2.00%)
|
3 |
3/390 (0.77%)
|
3 |
4/357 (1.12%)
|
4 |
Pharyngeal Disorders (Excl Infections And Neoplasms) |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Pneumothorax And Pleural Effusions Nec |
54/489 (11.04%)
|
74 |
26/150 (17.33%)
|
36 |
29/390 (7.44%)
|
39 |
67/357 (18.77%)
|
86 |
Pulmonary Hypertensions |
2/489 (0.41%)
|
2 |
1/150 (0.67%)
|
1 |
5/390 (1.28%)
|
5 |
0/357 (0.00%)
|
0 |
Pulmonary Oedemas |
23/489 (4.70%)
|
24 |
3/150 (2.00%)
|
3 |
9/390 (2.31%)
|
9 |
10/357 (2.80%)
|
10 |
Pulmonary Thrombotic And Embolic Conditions |
7/489 (1.43%)
|
7 |
1/150 (0.67%)
|
1 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Respiratory Failures (Excl Neonatal) |
54/489 (11.04%)
|
62 |
28/150 (18.67%)
|
29 |
36/390 (9.23%)
|
40 |
54/357 (15.13%)
|
68 |
Respiratory Tract Disorders Nec |
1/489 (0.20%)
|
1 |
1/150 (0.67%)
|
1 |
3/390 (0.77%)
|
3 |
2/357 (0.56%)
|
2 |
Tracheal Disorders (Excl Infections And Neoplasms) |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Upper Respiratory Tract Signs And Symptoms |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Skin and subcutaneous tissue disorders |
|
|
|
|
Bullous Conditions |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
2/390 (0.51%)
|
2 |
0/357 (0.00%)
|
0 |
Dermal And Epidermal Conditions Nec |
1/489 (0.20%)
|
1 |
1/150 (0.67%)
|
1 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Dermatitis And Eczema |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
2/357 (0.56%)
|
2 |
Dermatitis Ascribed To Specific Agent |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Purpura And Related Conditions |
2/489 (0.41%)
|
2 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Rashes, Eruptions And Exanthems Nec |
1/489 (0.20%)
|
1 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
0/357 (0.00%)
|
0 |
Skin And Subcutaneous Tissue Ulcerations |
3/489 (0.61%)
|
3 |
0/150 (0.00%)
|
0 |
0/390 (0.00%)
|
0 |
1/357 (0.28%)
|
1 |
Skin Haemorrhages |
0/489 (0.00%)
|
0 |
0/150 (0.00%)
|
0 |
1/390 (0.26%)
|
1 |
0/357 (0.00%)
|
0 |
Skin Injuries And Mechanical Dermatoses |
2/489 (0.41%)
|