AURORA: Crestor 10mg Versus Placebo in Subjects With End-stage Renal Disease (ESRD)

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00240331
• Collaborator: (none)
• Enrollment: 2,776
• Locations: 241
• Arms: 2
• Duration (Months): 69
• Patients Per Site: 11.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to see if rosuvastatin helps to reduce the number of heart attacks, strokes and cardiovascular deaths in patients undergoing haemodialysis.

Condition or Disease	Intervention/Treatment	Phase
Renal Failure	Drug: 10mg Rosuvastatin; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 2776 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Prevention
• Official Title: A Study to Evaluate the Use of Rosuvastatin in Subjects On Regular Haemodialysis: an Assessment of Survival and Cardiovascular Events (AURORA). A Double Blind, Randomised, Phase 3b, Parallel-group Study to Compare the Effects of Rosuvastatin With Placebo on Assessment of Survival & Cardiovascular Events When Given to Subjects With End-stage Renal Failure on Chronic Haemodialysis Treatment
• Study Start Date: Jan 1, 2003
• Actual Primary Completion Date: Oct 1, 2008
• Actual Study Completion Date: Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rosuvastatin 10mg	Drug: 10mg Rosuvastatin
Placebo Comparator: Placebo matching Placebo	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Number of Randomised Participants With a Major Cardiovascular Event (Non-fatal Stroke, Non-fatal Myocardial Infarction or Cardiovascular Death) [Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years]

Secondary Outcome Measures

1. Number of Randomised Participants That Died From Any Cause. [Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years]

2. Number of Randomised Participants With a Major Cardiovascular Event or That Died From Any Known Cause [Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years]

3. Number of Randomised Participants That Died From Cardiovascular Cause [Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years]

4. Number of Randomised Participants That Died From Non Cardiovascular Cause [Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years]

5. Number of Randomised Participants With an Atherosclerotic Cardiac Event (Non-fatal Myocardial Infarction or Coronary Heart Disease (CHD) Death) [Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years]

6. Number of Randomised Participants That Experienced a Procedure as a Result of Stenosis or Thrombosis of the Vascular Access (Arteriovenous (AV) Fistulas and Grafts Only) for Haemodialysis. [Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years]

7. Number of Randomised Participants That Experienced a Coronary or Peripheral Revascularisation (Including Above Ankle Limb Amputations). [Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female subjects with end-stage renal failure aged 50-80 years, who have received regular haemodialysis treatment for at least 3 months

Exclusion Criteria:

• Subjects will have no underlying condition that is expected to limit survival to less than 1 year and is also unrelated to end-stage renal disease (ESRD). Subjects should not have received a statin therapy within the past 6 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	St Leonards	New South Wales	Australia
2	Research Site	Herston	Queensland	Australia
3	Research Site	Bregenz		Austria
4	Research Site	Feldkirch-Tisis		Austria
5	Research Site	Graz		Austria
6	Research Site	Innsbruck		Austria
7	Research Site	Linz		Austria
8	Research Site	St. Poelten		Austria
9	Research Site	Wels		Austria
10	Research Site	Wien		Austria
11	Research Site	Aalst		Belgium
12	Research Site	Antwerpen		Belgium
13	Research Site	Brussels		Belgium
14	Research Site	La Louviere		Belgium
15	Research Site	Leuven		Belgium
16	Research Site	Liège		Belgium
17	Research Site	Curitiba	PR	Brazil
18	Research Site	Sao Paulo	SP	Brazil
19	Research Site	Pleven		Bulgaria
20	Research Site	Plovdiv		Bulgaria
21	Research Site	Sofia		Bulgaria
22	Research Site	Calgary	Alberta	Canada
23	Research Site	Edmonton	Alberta	Canada
24	Research Site	Lethbridge	Alberta	Canada
25	Research Site	Kelowna	British Columbia	Canada
26	Research Site	Vancouver	British Columbia	Canada
27	Research Site	Winnipeg	Manitoba	Canada
28	Research Site	Saint John	New Brunswick	Canada
29	Research Site	Halifax	Nova Scotia	Canada
30	Research Site	London	Ontario	Canada
31	Research Site	Mississauga	Ontario	Canada
32	Research Site	Scarborough	Ontario	Canada
33	Research Site	Toronto	Ontario	Canada
34	Research Site	York	Ontario	Canada
35	Research Site	Greenfield Park	Quebec	Canada
36	Research Site	Laval	Quebec	Canada
37	Research Site	Montreal	Quebec	Canada
38	Research Site	Trois-Rivieres	Quebec	Canada
39	Research Site	Kitchener		Canada
40	Research Site	Rosemount		Canada
41	Research Site	Hodonin		Czech Republic
42	Research Site	Hradec Kralove		Czech Republic
43	Research Site	Liberec		Czech Republic
44	Research Site	Pardubice		Czech Republic
45	Research Site	Praha 2		Czech Republic
46	Research Site	Praha 4		Czech Republic
47	Research Site	Praha 6		Czech Republic
48	Research Site	Tabor		Czech Republic
49	Research Site	Usti nad Labem		Czech Republic
50	Research Site	Fredericia		Denmark
51	Research Site	Frederiksberg		Denmark
52	Research Site	Herlev		Denmark
53	Research Site	Holbaek		Denmark
54	Research Site	Horsens		Denmark
55	Research Site	København Ø		Denmark
56	Research Site	Roskilde		Denmark
57	Research Site	Rønne		Denmark
58	Research Site	Slagelse		Denmark
59	Research Site	Sønderborg		Denmark
60	Research Site	Viborg		Denmark
61	Research Site	Helsinki		Finland
62	Research Site	Hyvinkaa		Finland
63	Research Site	Joensuu		Finland
64	Research Site	Kotka		Finland
65	Research Site	Kuopio		Finland
66	Research Site	Lahti		Finland
67	Research Site	Oulu		Finland
68	Research Site	Pori		Finland
69	Research Site	Tammisaari		Finland
70	Research Site	Tampere		Finland
71	Research Site	Turku		Finland
72	Research Site	Amiens		France
73	Research Site	Annonay Cedex		France
74	Research Site	Aubervilliers		France
75	Research Site	Beauvais		France
76	Research Site	Bethune Cedex		France
77	Research Site	Boulogne Sur Mer		France
78	Research Site	Chambery		France
79	Research Site	Champigny Sur Marne		France
80	Research Site	Colmar Cedex		France
81	Research Site	Creil Cedex 1		France
82	Research Site	Evreux Cedex		France
83	Research Site	Fleury Merogis		France
84	Research Site	Foix Cedex		France
85	Research Site	Le Kremlin-Bicetre		France
86	Research Site	Maubeuge		France
87	Research Site	Meaux		France
88	Research Site	Mont de Marsan Cedex		France
89	Research Site	Montbonnot Saint Martin		France
90	Research Site	Nimes		France
91	Research Site	Olivet		France
92	Research Site	Paris		France
93	Research Site	Quimper Cedex		France
94	Research Site	Saint Maurice		France
95	Research Site	Saint Michel		France
96	Research Site	Tournan En Brie		France
97	Research Site	Valenciennes Cedex		France
98	Research Site	Vandoeuvre Les Nancy		France
99	Research Site	Vichy		France
100	Research Site	Ansbach		Germany
101	Research Site	Aschaffenburg		Germany
102	Research Site	Bad Münder		Germany
103	Research Site	Berlin		Germany
104	Research Site	Bischofswerda		Germany
105	Research Site	Dresden		Germany
106	Research Site	Duisburg		Germany
107	Research Site	Düsseldorf		Germany
108	Research Site	Erlangen		Germany
109	Research Site	Frankfurt		Germany
110	Research Site	Freiburg		Germany
111	Research Site	Greifswald		Germany
112	Research Site	Hann Münden		Germany
113	Research Site	Ingolstadt		Germany
114	Research Site	Jena		Germany
115	Research Site	Kaufbeuren		Germany
116	Research Site	Luedenscheid		Germany
117	Research Site	Marktheidenfeld		Germany
118	Research Site	München		Germany
119	Research Site	Pfarrkirchen		Germany
120	Research Site	Pirmasens		Germany
121	Research Site	Regensburg		Germany
122	Research Site	Rostock		Germany
123	Research Site	Saarbrucken		Germany
124	Research Site	Tangermünde		Germany
125	Research Site	Waldshut		Germany
126	Research Site	Alexandroupoli		Greece
127	Research Site	Athens		Greece
128	Research Site	Ioannina		Greece
129	Research Site	Thessaloniki		Greece
130	Research Site	Veroia		Greece
131	Research Site	Budapest		Hungary
132	Research Site	Gyor		Hungary
133	Research Site	Miskolc		Hungary
134	Research Site	Nyiregyhaza		Hungary
135	Research Site	Szeged		Hungary
136	Research Site	Székesfehérvár		Hungary
137	Research Site	Veszprém		Hungary
138	Research Site	Reykjavik		Iceland
139	Research Site	Galway		Ireland
140	Research Site	Bergamo	BG	Italy
141	Research Site	Treviglio	BG	Italy
142	Research Site	Cremona	CR	Italy
143	Research Site	Genova	GE	Italy
144	Research Site	Lodi	LO	Italy
145	Research Site	Milano	Mi	Italy
146	Research Site	Rozzano	MI	Italy
147	Research Site	Reggio Calabria	RC	Italy
148	Research Site	Busto Arsizio	VA	Italy
149	Research Site	Seongnam-Si	Korea	Korea, Republic of
150	Research Site	Seoul	Korea	Korea, Republic of
151	Research Site	Mexico	D.f.	Mexico
152	Research Site	Acapulco	Guerrero	Mexico
153	Research Site	Guadalajara	Jalisco	Mexico
154	Research Site	Cuernavaca	Morelos	Mexico
155	Research Site	Monterrey	Nuevo Leon	Mexico
156	Research Site	Distrito Federal		Mexico
157	Research Site	San Luis Potosi		Mexico
158	Research Site	Alkmaar		Netherlands
159	Research Site	Almelo		Netherlands
160	Research Site	Amersfoort		Netherlands
161	Research Site	Amsterdam		Netherlands
162	Research Site	Arnhem		Netherlands
163	Research Site	Den Bosch		Netherlands
164	Research Site	Den Haag		Netherlands
165	Research Site	Deventer		Netherlands
166	Research Site	Dordrecht		Netherlands
167	Research Site	Emmen		Netherlands
168	Research Site	Groningen		Netherlands
169	Research Site	Leeuwarden		Netherlands
170	Research Site	Nieuwegein		Netherlands
171	Research Site	Rotterdam		Netherlands
172	Research Site	Sittard		Netherlands
173	Research Site	Tilburg		Netherlands
174	Research Site	Bergen		Norway
175	Research Site	Drammen		Norway
176	Research Site	Fredrikstad		Norway
177	Research Site	Lillehammer		Norway
178	Research Site	Lorenskog		Norway
179	Research Site	Oslo		Norway
180	Research Site	Skien		Norway
181	Research Site	Stavanger		Norway
182	Research Site	Trondheim		Norway
183	Research Site	Tønsberg		Norway
184	Research Site	Bialystok		Poland
185	Research Site	Gdansk		Poland
186	Research Site	Katowice		Poland
187	Research Site	Kraków		Poland
188	Research Site	Lublin		Poland
189	Research Site	Opole		Poland
190	Research Site	Plock		Poland
191	Research Site	Rybnik		Poland
192	Research Site	Wloclawek		Poland
193	Research Site	Eksjö		Sweden
194	Research Site	Eskilstuna		Sweden
195	Research Site	Falun		Sweden
196	Research Site	Gävle		Sweden
197	Research Site	Göteborg		Sweden
198	Research Site	Jönköping		Sweden
199	Research Site	Karlstad		Sweden
200	Research Site	Linköping		Sweden
201	Research Site	Lund		Sweden
202	Research Site	Mölndal		Sweden
203	Research Site	Norrköping		Sweden
204	Research Site	Skövde		Sweden
205	Research Site	Stockholm		Sweden
206	Research Site	Trollhättan		Sweden
207	Research Site	Uppsala		Sweden
208	Research Site	Örebro		Sweden
209	Research Site	Aarau		Switzerland
210	Research Site	Bern		Switzerland
211	Research Site	Geneve		Switzerland
212	Research Site	Lausanne		Switzerland
213	Research Site	St. Gallen		Switzerland
214	Research Site	Zürich		Switzerland
215	Research Site	Istanbul	Altunizade	Turkey
216	Research Site	Cebeci	Ankara	Turkey
217	Research Site	Kampus	Antalya	Turkey
218	Research Site	Antalya	Arapsuyu	Turkey
219	Research Site	Ankara	Besevler	Turkey
220	Research Site	Izmir	Bornova	Turkey
221	Research Site	Bursa	Gorukle	Turkey
222	Research Site	Istanbul	Haydarpasa	Turkey
223	Research Site	Antrim	Northern Ireland	United Kingdom
224	Research Site	Belfast	Northern Ireland	United Kingdom
225	Research Site	Newry	Northern Ireland	United Kingdom
226	Research Site	Omagh	Northern Ireland	United Kingdom
227	Research Site	Bradford		United Kingdom
228	Research Site	Dumfries		United Kingdom
229	Research Site	Dundee		United Kingdom
230	Research Site	Glasgow		United Kingdom
231	Research Site	Hull		United Kingdom
232	Research Site	Kilmarnock		United Kingdom
233	Research Site	Leeds		United Kingdom
234	Research Site	London		United Kingdom
235	Research Site	Manchester		United Kingdom
236	Research Site	Middlesborough		United Kingdom
237	Research Site	Newcastle		United Kingdom
238	Research Site	Plymouth		United Kingdom
239	Research Site	Rhyl		United Kingdom
240	Research Site	Sheffield		United Kingdom
241	Research Site	Surrey		United Kingdom

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: AstraZeneca Crestor Medical Sciences Director, MD, AstraZeneca

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00240331
• Other Study ID Numbers: 4522IL/0096; D3562C00096
• First Posted: Oct 18, 2005
• Last Update Posted: May 19, 2011
• Last Verified: May 1, 2011

• Keywords provided by , ,: End Stage Renal Failure
• Additional relevant MeSH terms: Renal Insufficiency; Rosuvastatin Calcium

Study Results

Participant Flow

Recruitment Details	Recruited patients were male or female with end-stage renal failure aged 50 to 80 years, who had received regular chronic haemodialysis treatment (including haemofiltration and hemodiafiltration ) for at least 3 months. They were recruited from 280 sites in 25 countries; recruitment started on 16 January 2003 and finished on 24 November 2004.
Pre-assignment Detail	After a two week screening period, eligible patients were randomly assigned to either rosuvastatin treatment (10mg/day) or placebo with a 1:1 randomisation ratio. Follow-up was planned to continue until the accrual of 805 major cardiovascular events

Arm/Group Title	Rosuvastatin 10mg	Placebo
Arm/Group Description	Rosuvastatin 10 mg oral tablets	Matching placebo
Period Title: Overall Study
STARTED	1389	1384
COMPLETED	1263	1250
NOT COMPLETED	126	134

Baseline Characteristics

Arm/Group Title	Rosuvastatin 10mg	Placebo	Total
Arm/Group Description	Rosuvastatin 10 mg oral tablets	Matching placebo	Total of all reporting groups
Overall Participants	1389	1384	2773
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	64.1 (8.6)	64.3 (8.7)	64.2 (8.6)
Sex: Female, Male (Count of Participants)
Female	538 38.7%	512 37%	1050 37.9%
Male	851 61.3%	872 63%	1723 62.1%

Outcome Measures

1. Primary Outcome

Title	Number of Randomised Participants With a Major Cardiovascular Event (Non-fatal Stroke, Non-fatal Myocardial Infarction or Cardiovascular Death)
Time Frame	Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rosuvastatin 10mg	Placebo
Arm/Group Description	Rosuvastatin 10 mg oral tablets	Matching placebo
Measure Participants	1389	1384
Number [Participants]	396 28.5%	408 29.5%

2. Secondary Outcome

Title	Number of Randomised Participants That Died From Any Cause.
Time Frame	Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rosuvastatin 10mg	Placebo
Arm/Group Description	Rosuvastatin 10 mg oral tablets	Matching placebo
Measure Participants	1389	1384
Number [Participants]	636 45.8%	660 47.7%

3. Secondary Outcome

Title	Number of Randomised Participants With a Major Cardiovascular Event or That Died From Any Known Cause
Time Frame	Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rosuvastatin 10mg	Placebo
Arm/Group Description	Rosuvastatin 10 mg oral tablets	Matching placebo
Measure Participants	1389	1384
Number [Participants]	614 44.2%	645 46.6%

4. Secondary Outcome

Title	Number of Randomised Participants That Died From Cardiovascular Cause
Time Frame	Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rosuvastatin 10mg	Placebo
Arm/Group Description	Rosuvastatin 10 mg oral tablets	Matching placebo
Measure Participants	1389	1384
Number [Participants]	324 23.3%	324 23.4%

5. Secondary Outcome

Title	Number of Randomised Participants That Died From Non Cardiovascular Cause
Time Frame	Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Number of Randomised Participants With an Atherosclerotic Cardiac Event (Non-fatal Myocardial Infarction or Coronary Heart Disease (CHD) Death)
Time Frame	Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rosuvastatin 10mg	Placebo
Arm/Group Description	Rosuvastatin 10 mg oral tablets	Matching placebo
Measure Participants	1389	1384
Number [Participants]	258 18.6%	256 18.5%

7. Secondary Outcome

Title	Number of Randomised Participants That Experienced a Procedure as a Result of Stenosis or Thrombosis of the Vascular Access (Arteriovenous (AV) Fistulas and Grafts Only) for Haemodialysis.
Time Frame	Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rosuvastatin 10mg	Placebo
Arm/Group Description	Rosuvastatin 10 mg oral tablets	Matching placebo
Measure Participants	1389	1384
Number [Participants]	390 28.1%	360 26%

8. Secondary Outcome

Title	Number of Randomised Participants That Experienced a Coronary or Peripheral Revascularisation (Including Above Ankle Limb Amputations).
Time Frame	Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rosuvastatin 10mg	Placebo
Arm/Group Description	Rosuvastatin 10 mg oral tablets	Matching placebo
Measure Participants	1389	1384
Number [Participants]	148 10.7%	152 11%

Adverse Events

Adverse Event Reporting Description	The Participant flow chart shows the ITT Population (all correctly randomized patients) and is correct. The adverse event denominator represents the safety population, all randomized patients who received study drug. Six placebo patients never received treatment. This explains the apparent discrepancy.
Arm/Group Title	Rosuvastatin 10mg		Placebo
Arm/Group Description	Rosuvastatin 10 mg oral tablets		Matching placebo
All Cause Mortality
	Rosuvastatin 10mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Rosuvastatin 10mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1140/ (NaN)		1159/ (NaN)
Blood and lymphatic system disorders
Thrombocytopenia	1/1389 (0.1%)		2/1378 (0.1%)
Nephrogenic Anaemia	2/1389 (0.1%)		1/1378 (0.1%)
Coagulopathy	0/1389 (0%)		1/1378 (0.1%)
Haemolytic Anaemia	0/1389 (0%)		1/1378 (0.1%)
Haemorrhagic Diathesis	0/1389 (0%)		1/1378 (0.1%)
Pancytopenia	0/1389 (0%)		1/1378 (0.1%)
Splenic Infarction	0/1389 (0%)		1/1378 (0.1%)
Anaemia Megaloblastic	1/1389 (0.1%)		0/1378 (0%)
Lymphadenopathy Mediastinal	1/1389 (0.1%)		0/1378 (0%)
Polycythaemia	1/1389 (0.1%)		0/1378 (0%)
Cardiac disorders
Myocardial Infarction	53/1389 (3.8%)		52/1378 (3.8%)
Atrial Fibrillation	39/1389 (2.8%)		45/1378 (3.3%)
Cardiac Failure	30/1389 (2.2%)		35/1378 (2.5%)
Angina Pectoris	21/1389 (1.5%)		31/1378 (2.2%)
Cardiac Arrest	22/1389 (1.6%)		26/1378 (1.9%)
Acute Myocardial Infarction	13/1389 (0.9%)		10/1378 (0.7%)
Cardiac Failure Congestive	7/1389 (0.5%)		12/1378 (0.9%)
Bradycardia	12/1389 (0.9%)		5/1378 (0.4%)
Angina Unstable	9/1389 (0.6%)		10/1378 (0.7%)
Myocardial Ischaemia	6/1389 (0.4%)		10/1378 (0.7%)
Atrioventricular Block Complete	10/1389 (0.7%)		6/1378 (0.4%)
Coronary Artery Disease	10/1389 (0.7%)		7/1378 (0.5%)
Arrhythmia	8/1389 (0.6%)		9/1378 (0.7%)
Acute Coronary Syndrome	9/1389 (0.6%)		5/1378 (0.4%)
Aortic Valve Stenosis	8/1389 (0.6%)		5/1378 (0.4%)
Cardio-Respiratory Arrest	6/1389 (0.4%)		5/1378 (0.4%)
Coronary Artery Stenosis	6/1389 (0.4%)		4/1378 (0.3%)
Ventricular Tachycardia	6/1389 (0.4%)		3/1378 (0.2%)
Cardiac Failure Acute	5/1389 (0.4%)		5/1378 (0.4%)
Tachycardia	1/1389 (0.1%)		4/1378 (0.3%)
Atrioventricular Block	4/1389 (0.3%)		1/1378 (0.1%)
Ventricular Fibrillation	4/1389 (0.3%)		1/1378 (0.1%)
Atrial Flutter	3/1389 (0.2%)		3/1378 (0.2%)
Cardiac Asthma	1/1389 (0.1%)		3/1378 (0.2%)
Cardiogenic Shock	2/1389 (0.1%)		3/1378 (0.2%)
Hypertensive Cardiomyopathy	0/1389 (0%)		3/1378 (0.2%)
Acute Left Ventricular Failure	3/1389 (0.2%)		0/1378 (0%)
Pericarditis	3/1389 (0.2%)		0/1378 (0%)
Sick Sinus Syndrome	3/1389 (0.2%)		0/1378 (0%)
Supraventricular Tachycardia	3/1389 (0.2%)		1/1378 (0.1%)
Cardiopulmonary Failure	2/1389 (0.1%)		2/1378 (0.1%)
Congestive Cardiomyopathy	2/1389 (0.1%)		2/1378 (0.1%)
Pericardial Effusion	0/1389 (0%)		2/1378 (0.1%)
Atrioventricular Block Second Degree	2/1389 (0.1%)		0/1378 (0%)
Cardiac Tamponade	2/1389 (0.1%)		0/1378 (0%)
Palpitations	2/1389 (0.1%)		0/1378 (0%)
Arrhythmia Supraventricular	0/1389 (0%)		1/1378 (0.1%)
Bundle Branch Block Right	0/1389 (0%)		1/1378 (0.1%)
Coronary Artery Insufficiency	0/1389 (0%)		1/1378 (0.1%)
Ischaemic Cardiomyopathy	0/1389 (0%)		1/1378 (0.1%)
Pericarditis Constrictive	0/1389 (0%)		1/1378 (0.1%)
Prinzmetal Angina	0/1389 (0%)		1/1378 (0.1%)
Right Ventricular Failure	0/1389 (0%)		1/1378 (0.1%)
Silent Myocardial Infarction	0/1389 (0%)		1/1378 (0.1%)
Sinus Arrhythmia	0/1389 (0%)		1/1378 (0.1%)
Sinus Bradycardia	0/1389 (0%)		1/1378 (0.1%)
Sinus Tachycardia	0/1389 (0%)		1/1378 (0.1%)
Trifascicular Block	0/1389 (0%)		1/1378 (0.1%)
Ventricular Extrasystoles	1/1389 (0.1%)		1/1378 (0.1%)
Atrioventricular Block First Degree	1/1389 (0.1%)		0/1378 (0%)
Cardiac Failure Chronic	1/1389 (0.1%)		0/1378 (0%)
Cardiac Failure High Output	1/1389 (0.1%)		0/1378 (0%)
Diastolic Dysfunction	1/1389 (0.1%)		0/1378 (0%)
Hypertensive Heart Disease	1/1389 (0.1%)		0/1378 (0%)
Nodal Rhythm	1/1389 (0.1%)		0/1378 (0%)
Pericardial Haemorrhage	1/1389 (0.1%)		0/1378 (0%)
Tachyarrhythmia	1/1389 (0.1%)		0/1378 (0%)
Torsade De Pointes	1/1389 (0.1%)		0/1378 (0%)
Ventricular Arrhythmia	1/1389 (0.1%)		0/1378 (0%)
Congenital, familial and genetic disorders
Atrial Septal Defect	0/1389 (0%)		1/1378 (0.1%)
Gastrointestinal Angiodysplasia Haemorrhagic	0/1389 (0%)		1/1378 (0.1%)
Gastrointestinal Angiodysplasia	1/1389 (0.1%)		0/1378 (0%)
Polycystic Liver Disease	1/1389 (0.1%)		0/1378 (0%)
Pyloric Stenosis	1/1389 (0.1%)		0/1378 (0%)
Ear and labyrinth disorders
Meniere's Disease	0/1389 (0%)		1/1378 (0.1%)
Sudden Hearing Loss	0/1389 (0%)		1/1378 (0.1%)
Tinnitus	0/1389 (0%)		1/1378 (0.1%)
Vertigo	1/1389 (0.1%)		1/1378 (0.1%)
Vertigo Positional	1/1389 (0.1%)		0/1378 (0%)
Endocrine disorders
Hyperparathyroidism	18/1389 (1.3%)		9/1378 (0.7%)
Hyperparathyroidism Secondary	7/1389 (0.5%)		7/1378 (0.5%)
Hyperparathyroidism Tertiary	3/1389 (0.2%)		1/1378 (0.1%)
Hyperthyroidism	0/1389 (0%)		2/1378 (0.1%)
Hypopituitarism	1/1389 (0.1%)		0/1378 (0%)
Eye disorders
Cataract	16/1389 (1.2%)		11/1378 (0.8%)
Vitreous Haemorrhage	3/1389 (0.2%)		3/1378 (0.2%)
Angle Closure Glaucoma	2/1389 (0.1%)		1/1378 (0.1%)
Glaucoma	2/1389 (0.1%)		1/1378 (0.1%)
Papilloedema	1/1389 (0.1%)		1/1378 (0.1%)
Retinal Detachment	0/1389 (0%)		1/1378 (0.1%)
Retinal Vein Occlusion	0/1389 (0%)		1/1378 (0.1%)
Retinopathy	0/1389 (0%)		1/1378 (0.1%)
Diabetic Retinopathy	1/1389 (0.1%)		0/1378 (0%)
Diplopia	1/1389 (0.1%)		0/1378 (0%)
Endophthalmitis	1/1389 (0.1%)		0/1378 (0%)
Eye Haemorrhage	1/1389 (0.1%)		0/1378 (0%)
Retinal Artery Occlusion	1/1389 (0.1%)		0/1378 (0%)
Gastrointestinal disorders
Gastrointestinal Haemorrhage	25/1389 (1.8%)		18/1378 (1.3%)
Abdominal Pain	17/1389 (1.2%)		12/1378 (0.9%)
Diarrhoea	13/1389 (0.9%)		9/1378 (0.7%)
Gastritis	9/1389 (0.6%)		4/1378 (0.3%)
Peritonitis	9/1389 (0.6%)		8/1378 (0.6%)
Oesophagitis	2/1389 (0.1%)		8/1378 (0.6%)
Vomiting	7/1389 (0.5%)		7/1378 (0.5%)
Upper Gastrointestinal Haemorrhage	2/1389 (0.1%)		6/1378 (0.4%)
Abdominal Pain Upper	5/1389 (0.4%)		5/1378 (0.4%)
Colitis Ischaemic	3/1389 (0.2%)		5/1378 (0.4%)
Duodenal Ulcer Haemorrhage	1/1389 (0.1%)		5/1378 (0.4%)
Gastric Ulcer Haemorrhage	5/1389 (0.4%)		5/1378 (0.4%)
Gastritis Erosive	1/1389 (0.1%)		5/1378 (0.4%)
Inguinal Hernia	1/1389 (0.1%)		5/1378 (0.4%)
Melaena	5/1389 (0.4%)		5/1378 (0.4%)
Gastric Ulcer	4/1389 (0.3%)		4/1378 (0.3%)
Haematemesis	4/1389 (0.3%)		4/1378 (0.3%)
Ileus	2/1389 (0.1%)		4/1378 (0.3%)
Colitis	4/1389 (0.3%)		1/1378 (0.1%)
Intestinal Ischaemia	4/1389 (0.3%)		1/1378 (0.1%)
Subileus	4/1389 (0.3%)		0/1378 (0%)
Colonic Polyp	3/1389 (0.2%)		3/1378 (0.2%)
Haemorrhoidal Haemorrhage	3/1389 (0.2%)		3/1378 (0.2%)
Pancreatitis	2/1389 (0.1%)		3/1378 (0.2%)
Rectal Haemorrhage	3/1389 (0.2%)		3/1378 (0.2%)
Small Intestinal Obstruction	0/1389 (0%)		3/1378 (0.2%)
Constipation	3/1389 (0.2%)		2/1378 (0.1%)
Diverticulum Intestinal	3/1389 (0.2%)		0/1378 (0%)
Duodenal Ulcer	3/1389 (0.2%)		2/1378 (0.1%)
Intestinal Haemorrhage	3/1389 (0.2%)		1/1378 (0.1%)
Abdominal Symptom	0/1389 (0%)		2/1378 (0.1%)
Enteritis	0/1389 (0%)		2/1378 (0.1%)
Gastric Polyps	0/1389 (0%)		2/1378 (0.1%)
Intra-Abdominal Haemorrhage	2/1389 (0.1%)		2/1378 (0.1%)
Lower Gastrointestinal Haemorrhage	0/1389 (0%)		2/1378 (0.1%)
Sigmoiditis	0/1389 (0%)		2/1378 (0.1%)
Umbilical Hernia	1/1389 (0.1%)		2/1378 (0.1%)
Ascites	2/1389 (0.1%)		1/1378 (0.1%)
Intestinal Infarction	2/1389 (0.1%)		1/1378 (0.1%)
Intestinal Obstruction	2/1389 (0.1%)		1/1378 (0.1%)
Nausea	2/1389 (0.1%)		1/1378 (0.1%)
Peptic Ulcer	2/1389 (0.1%)		0/1378 (0%)
Colonic Pseudo-Obstruction	0/1389 (0%)		1/1378 (0.1%)
Crohn's Disease	0/1389 (0%)		1/1378 (0.1%)
Diverticulum	0/1389 (0%)		1/1378 (0.1%)
Dyspepsia	1/1389 (0.1%)		1/1378 (0.1%)
Enterocolitis	0/1389 (0%)		1/1378 (0.1%)
Enterocutaneous Fistula	0/1389 (0%)		1/1378 (0.1%)
Enterovesical Fistula	0/1389 (0%)		1/1378 (0.1%)
Faecaloma	1/1389 (0.1%)		1/1378 (0.1%)
Gastric Haemorrhage	1/1389 (0.1%)		1/1378 (0.1%)
Gastric Stenosis	0/1389 (0%)		1/1378 (0.1%)
Gastric Ulcer Perforation	0/1389 (0%)		1/1378 (0.1%)
Gastritis Haemorrhagic	1/1389 (0.1%)		1/1378 (0.1%)
Gastrointestinal Ischaemia	0/1389 (0%)		1/1378 (0.1%)
Gastrointestinal Perforation	1/1389 (0.1%)		1/1378 (0.1%)
Gastrooesophageal Reflux Disease	0/1389 (0%)		1/1378 (0.1%)
Haematochezia	1/1389 (0.1%)		1/1378 (0.1%)
Haemorrhoids	0/1389 (0%)		1/1378 (0.1%)
Ileitis	0/1389 (0%)		1/1378 (0.1%)
Impaired Gastric Emptying	1/1389 (0.1%)		1/1378 (0.1%)
Inguinal Hernia, Obstructive	0/1389 (0%)		1/1378 (0.1%)
Intestinal Angina	0/1389 (0%)		1/1378 (0.1%)
Intestinal Perforation	0/1389 (0%)		1/1378 (0.1%)
Intra-Abdominal Haematoma	0/1389 (0%)		1/1378 (0.1%)
Large Intestine Perforation	0/1389 (0%)		1/1378 (0.1%)
Mechanical Ileus	0/1389 (0%)		1/1378 (0.1%)
Mesenteric Artery Embolism	1/1389 (0.1%)		1/1378 (0.1%)
Mesenteric Vascular Insufficiency	0/1389 (0%)		1/1378 (0.1%)
Mouth Haemorrhage	0/1389 (0%)		1/1378 (0.1%)
Oesophagitis Haemorrhagic	0/1389 (0%)		1/1378 (0.1%)
Pancreatic Cyst	1/1389 (0.1%)		1/1378 (0.1%)
Periodontitis	1/1389 (0.1%)		1/1378 (0.1%)
Proctocolitis	0/1389 (0%)		1/1378 (0.1%)
Rectal Polyp	1/1389 (0.1%)		1/1378 (0.1%)
Sclerosing Encapsulating Peritonitis	0/1389 (0%)		1/1378 (0.1%)
Abdominal Hernia	1/1389 (0.1%)		0/1378 (0%)
Acute Abdomen	1/1389 (0.1%)		0/1378 (0%)
Anal Fistula	1/1389 (0.1%)		0/1378 (0%)
Dental Caries	1/1389 (0.1%)		0/1378 (0%)
Diarrhoea Haemorrhagic	1/1389 (0.1%)		0/1378 (0%)
Diverticular Perforation	1/1389 (0.1%)		0/1378 (0%)
Duodenitis	1/1389 (0.1%)		0/1378 (0%)
Food Poisoning	1/1389 (0.1%)		0/1378 (0%)
Gastroduodenitis	1/1389 (0.1%)		0/1378 (0%)
Gastrointestinal Motility Disorder	1/1389 (0.1%)		0/1378 (0%)
Gingival Bleeding	1/1389 (0.1%)		0/1378 (0%)
Ileus Paralytic	1/1389 (0.1%)		0/1378 (0%)
Intestinal Strangulation	1/1389 (0.1%)		0/1378 (0%)
Large Intestinal Haemorrhage	1/1389 (0.1%)		0/1378 (0%)
Mesenteric Artery Stenosis	1/1389 (0.1%)		0/1378 (0%)
Mesenteric Artery Thrombosis	1/1389 (0.1%)		0/1378 (0%)
Oesophageal Ulcer	1/1389 (0.1%)		0/1378 (0%)
Oesophageal Varices Haemorrhage	1/1389 (0.1%)		0/1378 (0%)
Pancreatitis Acute	1/1389 (0.1%)		0/1378 (0%)
Peritoneal Effusion	1/1389 (0.1%)		0/1378 (0%)
Reflux Oesophagitis	1/1389 (0.1%)		0/1378 (0%)
Retroperitoneal Effusion	1/1389 (0.1%)		0/1378 (0%)
Retroperitoneal Haematoma	1/1389 (0.1%)		0/1378 (0%)
Varices Oesophageal	1/1389 (0.1%)		0/1378 (0%)
General disorders
Sudden Death	33/1389 (2.4%)		30/1378 (2.2%)
Death	30/1389 (2.2%)		30/1378 (2.2%)
Catheter Related Complication	14/1389 (1%)		17/1378 (1.2%)
Pyrexia	13/1389 (0.9%)		15/1378 (1.1%)
Catheter Thrombosis	4/1389 (0.3%)		10/1378 (0.7%)
Malaise	5/1389 (0.4%)		10/1378 (0.7%)
Sudden Cardiac Death	8/1389 (0.6%)		2/1378 (0.1%)
Catheter Site Haemorrhage	5/1389 (0.4%)		7/1378 (0.5%)
General Physical Health Deterioration	4/1389 (0.3%)		7/1378 (0.5%)
Non-Cardiac Chest Pain	6/1389 (0.4%)		2/1378 (0.1%)
Chest Pain	3/1389 (0.2%)		5/1378 (0.4%)
Asthenia	3/1389 (0.2%)		3/1378 (0.2%)
Cardiac Death	2/1389 (0.1%)		3/1378 (0.2%)
Chills	0/1389 (0%)		3/1378 (0.2%)
Discomfort	2/1389 (0.1%)		3/1378 (0.2%)
Fatigue	3/1389 (0.2%)		3/1378 (0.2%)
Inflammation	1/1389 (0.1%)		2/1378 (0.1%)
Multi-Organ Failure	1/1389 (0.1%)		2/1378 (0.1%)
Oedema Peripheral	2/1389 (0.1%)		2/1378 (0.1%)
Wound Necrosis	2/1389 (0.1%)		2/1378 (0.1%)
Gait Disturbance	2/1389 (0.1%)		0/1378 (0%)
Catheter Site Haematoma	0/1389 (0%)		1/1378 (0.1%)
Catheter Site Inflammation	0/1389 (0%)		1/1378 (0.1%)
Haemorrhagic Cyst	0/1389 (0%)		1/1378 (0.1%)
Hyperpyrexia	1/1389 (0.1%)		1/1378 (0.1%)
Ulcer Haemorrhage	0/1389 (0%)		1/1378 (0.1%)
Chest Discomfort	1/1389 (0.1%)		0/1378 (0%)
Drug Interaction	1/1389 (0.1%)		0/1378 (0%)
Hypothermia	1/1389 (0.1%)		0/1378 (0%)
Influenza Like Illness	1/1389 (0.1%)		0/1378 (0%)
Necrosis	1/1389 (0.1%)		0/1378 (0%)
Pain	1/1389 (0.1%)		0/1378 (0%)
Systemic Inflammatory Response Syndrome	1/1389 (0.1%)		0/1378 (0%)
Hepatobiliary disorders
Cholelithiasis	9/1389 (0.6%)		2/1378 (0.1%)
Cholecystitis	5/1389 (0.4%)		5/1378 (0.4%)
Cholecystitis Acute	2/1389 (0.1%)		2/1378 (0.1%)
Biliary Dilatation	2/1389 (0.1%)		0/1378 (0%)
Cholangitis	2/1389 (0.1%)		1/1378 (0.1%)
Bile Duct Stone	1/1389 (0.1%)		1/1378 (0.1%)
Gallbladder Perforation	0/1389 (0%)		1/1378 (0.1%)
Hepatic Cyst	0/1389 (0%)		1/1378 (0.1%)
Hepatitis	1/1389 (0.1%)		1/1378 (0.1%)
Hepatitis Toxic	0/1389 (0%)		1/1378 (0.1%)
Jaundice	0/1389 (0%)		1/1378 (0.1%)
Bile Duct Obstruction	1/1389 (0.1%)		0/1378 (0%)
Biliary Colic	1/1389 (0.1%)		0/1378 (0%)
Cholecystitis Chronic	1/1389 (0.1%)		0/1378 (0%)
Hepatic Cirrhosis	1/1389 (0.1%)		0/1378 (0%)
Hepatic Function Abnormal	1/1389 (0.1%)		0/1378 (0%)
Hepatic Necrosis	1/1389 (0.1%)		0/1378 (0%)
Hyperbilirubinaemia	1/1389 (0.1%)		0/1378 (0%)
Portal Vein Occlusion	1/1389 (0.1%)		0/1378 (0%)
Immune system disorders
Anaphylactic Reaction	0/1389 (0%)		2/1378 (0.1%)
Amyloidosis	0/1389 (0%)		1/1378 (0.1%)
Kidney Transplant Rejection	0/1389 (0%)		1/1378 (0.1%)
Anaphylactic Shock	1/1389 (0.1%)		0/1378 (0%)
Infections and infestations
Pneumonia	92/1389 (6.6%)		96/1378 (7%)
Sepsis	65/1389 (4.7%)		70/1378 (5.1%)
Bronchitis	20/1389 (1.4%)		22/1378 (1.6%)
Bronchopneumonia	19/1389 (1.4%)		18/1378 (1.3%)
Gastroenteritis	19/1389 (1.4%)		12/1378 (0.9%)
Urinary Tract Infection	16/1389 (1.2%)		10/1378 (0.7%)
Catheter Related Infection	14/1389 (1%)		15/1378 (1.1%)
Arteriovenous Fistula Site Infection	15/1389 (1.1%)		13/1378 (0.9%)
Gangrene	10/1389 (0.7%)		14/1378 (1%)
Septic Shock	13/1389 (0.9%)		9/1378 (0.7%)
Cellulitis	11/1389 (0.8%)		11/1378 (0.8%)
Staphylococcal Sepsis	10/1389 (0.7%)		11/1378 (0.8%)
Respiratory Tract Infection	6/1389 (0.4%)		10/1378 (0.7%)
Arthritis Bacterial	3/1389 (0.2%)		9/1378 (0.7%)
Bacteraemia	9/1389 (0.6%)		8/1378 (0.6%)
Lobar Pneumonia	5/1389 (0.4%)		8/1378 (0.6%)
Localised Infection	8/1389 (0.6%)		8/1378 (0.6%)
Diverticulitis	5/1389 (0.4%)		7/1378 (0.5%)
Erysipelas	6/1389 (0.4%)		7/1378 (0.5%)
Viral Infection	7/1389 (0.5%)		5/1378 (0.4%)
Catheter Sepsis	4/1389 (0.3%)		6/1378 (0.4%)
Endocarditis	6/1389 (0.4%)		6/1378 (0.4%)
Infection	5/1389 (0.4%)		6/1378 (0.4%)
Lower Respiratory Tract Infection	6/1389 (0.4%)		6/1378 (0.4%)
Postoperative Wound Infection	6/1389 (0.4%)		6/1378 (0.4%)
Infected Skin Ulcer	6/1389 (0.4%)		2/1378 (0.1%)
Appendicitis	4/1389 (0.3%)		5/1378 (0.4%)
Arteriovenous Graft Site Infection	5/1389 (0.4%)		5/1378 (0.4%)
Clostridium Difficile Colitis	0/1389 (0%)		5/1378 (0.4%)
Osteomyelitis	5/1389 (0.4%)		5/1378 (0.4%)
Shunt Infection	3/1389 (0.2%)		5/1378 (0.4%)
Staphylococcal Infection	2/1389 (0.1%)		5/1378 (0.4%)
Central Line Infection	5/1389 (0.4%)		4/1378 (0.3%)
Wound Infection	5/1389 (0.4%)		3/1378 (0.2%)
Catheter Site Infection	3/1389 (0.2%)		4/1378 (0.3%)
Lung Infection	4/1389 (0.3%)		4/1378 (0.3%)
Graft Infection	4/1389 (0.3%)		1/1378 (0.1%)
Cystitis	0/1389 (0%)		3/1378 (0.2%)
Hepatitis C	0/1389 (0%)		3/1378 (0.2%)
Herpes Zoster	2/1389 (0.1%)		3/1378 (0.2%)
Intervertebral Discitis	1/1389 (0.1%)		3/1378 (0.2%)
Staphylococcal Bacteraemia	2/1389 (0.1%)		3/1378 (0.2%)
Arthritis Infective	3/1389 (0.2%)		1/1378 (0.1%)
Bacterial Infection	3/1389 (0.2%)		0/1378 (0%)
Device Related Infection	3/1389 (0.2%)		1/1378 (0.1%)
Gastroenteritis Viral	3/1389 (0.2%)		0/1378 (0%)
Post Procedural Infection	3/1389 (0.2%)		1/1378 (0.1%)
Postoperative Abscess	3/1389 (0.2%)		0/1378 (0%)
Renal Cyst Infection	3/1389 (0.2%)		2/1378 (0.1%)
Subcutaneous Abscess	3/1389 (0.2%)		0/1378 (0%)
Upper Respiratory Tract Infection	3/1389 (0.2%)		0/1378 (0%)
Abdominal Wall Abscess	0/1389 (0%)		2/1378 (0.1%)
Abscess Limb	1/1389 (0.1%)		2/1378 (0.1%)
Bacterial Sepsis	2/1389 (0.1%)		2/1378 (0.1%)
Diabetic Gangrene	2/1389 (0.1%)		2/1378 (0.1%)
Empyema	1/1389 (0.1%)		2/1378 (0.1%)
Endocarditis Bacterial	1/1389 (0.1%)		2/1378 (0.1%)
Enterococcal Sepsis	0/1389 (0%)		2/1378 (0.1%)
Hepatic Cyst Infection	2/1389 (0.1%)		2/1378 (0.1%)
Influenza	1/1389 (0.1%)		2/1378 (0.1%)
Meningitis	1/1389 (0.1%)		2/1378 (0.1%)
Nasopharyngitis	0/1389 (0%)		2/1378 (0.1%)
Pyelonephritis	2/1389 (0.1%)		2/1378 (0.1%)
Pyonephrosis	2/1389 (0.1%)		2/1378 (0.1%)
Skin Infection	2/1389 (0.1%)		2/1378 (0.1%)
Streptococcal Sepsis	0/1389 (0%)		2/1378 (0.1%)
Cytomegalovirus Infection	2/1389 (0.1%)		1/1378 (0.1%)
Pulmonary Tuberculosis	2/1389 (0.1%)		1/1378 (0.1%)
Tooth Infection	2/1389 (0.1%)		1/1378 (0.1%)
Abscess	0/1389 (0%)		1/1378 (0.1%)
Abscess Intestinal	0/1389 (0%)		1/1378 (0.1%)
Abscess Neck	0/1389 (0%)		1/1378 (0.1%)
Anal Abscess	0/1389 (0%)		1/1378 (0.1%)
Arteriosclerotic Gangrene	1/1389 (0.1%)		1/1378 (0.1%)
Bone Abscess	0/1389 (0%)		1/1378 (0.1%)
Bronchiectasis	0/1389 (0%)		1/1378 (0.1%)
Candida Sepsis	0/1389 (0%)		1/1378 (0.1%)
Escherichia Infection	1/1389 (0.1%)		1/1378 (0.1%)
Escherichia Sepsis	1/1389 (0.1%)		1/1378 (0.1%)
Febrile Infection	0/1389 (0%)		1/1378 (0.1%)
Fungal Sepsis	0/1389 (0%)		1/1378 (0.1%)
Gallbladder Abscess	0/1389 (0%)		1/1378 (0.1%)
Gallbladder Empyema	0/1389 (0%)		1/1378 (0.1%)
Groin Abscess	0/1389 (0%)		1/1378 (0.1%)
Haemophilus Infection	0/1389 (0%)		1/1378 (0.1%)
Helicobacter Gastritis	0/1389 (0%)		1/1378 (0.1%)
Hepatitis B	0/1389 (0%)		1/1378 (0.1%)
Hypopyon	0/1389 (0%)		1/1378 (0.1%)
Klebsiella Infection	0/1389 (0%)		1/1378 (0.1%)
Klebsiella Sepsis	1/1389 (0.1%)		1/1378 (0.1%)
Listeriosis	0/1389 (0%)		1/1378 (0.1%)
Liver Abscess	1/1389 (0.1%)		1/1378 (0.1%)
Mastoiditis	0/1389 (0%)		1/1378 (0.1%)
Myocarditis Septic	0/1389 (0%)		1/1378 (0.1%)
Oesophageal Candidiasis	1/1389 (0.1%)		1/1378 (0.1%)
Oral Fungal Infection	0/1389 (0%)		1/1378 (0.1%)
Orchitis	1/1389 (0.1%)		1/1378 (0.1%)
Pancreas Infection	0/1389 (0%)		1/1378 (0.1%)
Pelvic Abscess	0/1389 (0%)		1/1378 (0.1%)
Pelvic Infection	0/1389 (0%)		1/1378 (0.1%)
Penile Infection	0/1389 (0%)		1/1378 (0.1%)
Perinephric Abscess	1/1389 (0.1%)		1/1378 (0.1%)
Peritoneal Infection	0/1389 (0%)		1/1378 (0.1%)
Pneumonia Bacterial	1/1389 (0.1%)		1/1378 (0.1%)
Pneumonia Moraxella	0/1389 (0%)		1/1378 (0.1%)
Pneumonia Pneumococcal	0/1389 (0%)		1/1378 (0.1%)
Pseudomembranous Colitis	0/1389 (0%)		1/1378 (0.1%)
Pseudomonas Infection	0/1389 (0%)		1/1378 (0.1%)
Pyothorax	1/1389 (0.1%)		1/1378 (0.1%)
Rectal Abscess	0/1389 (0%)		1/1378 (0.1%)
Respiratory Tract Infection Viral	0/1389 (0%)		1/1378 (0.1%)
Salmonellosis	0/1389 (0%)		1/1378 (0.1%)
Scrotal Infection	0/1389 (0%)		1/1378 (0.1%)
Sepsis Syndrome	0/1389 (0%)		1/1378 (0.1%)
Streptococcal Bacteraemia	0/1389 (0%)		1/1378 (0.1%)
Streptococcal Infection	0/1389 (0%)		1/1378 (0.1%)
Tuberculosis	1/1389 (0.1%)		1/1378 (0.1%)
Urinary Tract Infection Staphylococcal	0/1389 (0%)		1/1378 (0.1%)
Urosepsis	1/1389 (0.1%)		1/1378 (0.1%)
Abdominal Infection	1/1389 (0.1%)		0/1378 (0%)
Abdominal Sepsis	1/1389 (0.1%)		0/1378 (0%)
Bronchitis Viral	1/1389 (0.1%)		0/1378 (0%)
Chronic Tonsillitis	1/1389 (0.1%)		0/1378 (0%)
Citrobacter Sepsis	1/1389 (0.1%)		0/1378 (0%)
Clostridial Infection	1/1389 (0.1%)		0/1378 (0%)
Clostridium Colitis	1/1389 (0.1%)		0/1378 (0%)
Diabetic Foot Infection	1/1389 (0.1%)		0/1378 (0%)
Diarrhoea Infectious	1/1389 (0.1%)		0/1378 (0%)
Endocarditis Staphylococcal	1/1389 (0.1%)		0/1378 (0%)
Enteritis Infectious	1/1389 (0.1%)		0/1378 (0%)
Escherichia Bacteraemia	1/1389 (0.1%)		0/1378 (0%)
Eye Infection	1/1389 (0.1%)		0/1378 (0%)
Fungal Infection	1/1389 (0.1%)		0/1378 (0%)
Furuncle	1/1389 (0.1%)		0/1378 (0%)
Herpes Simplex	1/1389 (0.1%)		0/1378 (0%)
Infective Exacerbation Of Chronic Obstructive Airways Disease	1/1389 (0.1%)		0/1378 (0%)
Infective Spondylitis	1/1389 (0.1%)		0/1378 (0%)
Lung Abscess	1/1389 (0.1%)		0/1378 (0%)
Lung Infection Pseudomonal	1/1389 (0.1%)		0/1378 (0%)
Meningitis Bacterial	1/1389 (0.1%)		0/1378 (0%)
Otitis Externa	1/1389 (0.1%)		0/1378 (0%)
Otitis Media	1/1389 (0.1%)		0/1378 (0%)
Peridiverticular Abscess	1/1389 (0.1%)		0/1378 (0%)
Perihepatic Abscess	1/1389 (0.1%)		0/1378 (0%)
Peritonitis Bacterial	1/1389 (0.1%)		0/1378 (0%)
Pneumococcal Sepsis	1/1389 (0.1%)		0/1378 (0%)
Pneumonia Klebsiella	1/1389 (0.1%)		0/1378 (0%)
Pseudomonal Sepsis	1/1389 (0.1%)		0/1378 (0%)
Pyelonephritis Acute	1/1389 (0.1%)		0/1378 (0%)
Respiratory Tract Infection Bacterial	1/1389 (0.1%)		0/1378 (0%)
Sinusitis	1/1389 (0.1%)		0/1378 (0%)
Toxoplasmosis	1/1389 (0.1%)		0/1378 (0%)
Tuberculous Pleurisy	1/1389 (0.1%)		0/1378 (0%)
Urinary Tract Infection Pseudomonal	1/1389 (0.1%)		0/1378 (0%)
Injury, poisoning and procedural complications
Arteriovenous Fistula Site Complication	54/1389 (3.9%)		60/1378 (4.4%)
Arteriovenous Fistula Thrombosis	53/1389 (3.8%)		45/1378 (3.3%)
Vascular Access Complication	30/1389 (2.2%)		40/1378 (2.9%)
Arteriovenous Fistula Site Haemorrhage	20/1389 (1.4%)		24/1378 (1.7%)
Femur Fracture	7/1389 (0.5%)		19/1378 (1.4%)
Arteriovenous Fistula Aneurysm	13/1389 (0.9%)		18/1378 (1.3%)
Femoral Neck Fracture	13/1389 (0.9%)		14/1378 (1%)
Shunt Thrombosis	12/1389 (0.9%)		9/1378 (0.7%)
Shunt Stenosis	11/1389 (0.8%)		4/1378 (0.3%)
Vascular Graft Complication	11/1389 (0.8%)		8/1378 (0.6%)
Graft Thrombosis	4/1389 (0.3%)		10/1378 (0.7%)
Arteriovenous Graft Thrombosis	10/1389 (0.7%)		7/1378 (0.5%)
Arteriovenous Fistula Occlusion	4/1389 (0.3%)		9/1378 (0.7%)
Vascular Graft Occlusion	4/1389 (0.3%)		9/1378 (0.7%)
Pelvic Fracture	9/1389 (0.6%)		7/1378 (0.5%)
Haemodialysis-Induced Symptom	3/1389 (0.2%)		8/1378 (0.6%)
Hip Fracture	8/1389 (0.6%)		4/1378 (0.3%)
Post Procedural Haemorrhage	7/1389 (0.5%)		3/1378 (0.2%)
Procedural Hypotension	7/1389 (0.5%)		4/1378 (0.3%)
Rib Fracture	4/1389 (0.3%)		6/1378 (0.4%)
Fall	6/1389 (0.4%)		0/1378 (0%)
Contusion	1/1389 (0.1%)		5/1378 (0.4%)
Humerus Fracture	4/1389 (0.3%)		5/1378 (0.4%)
Post Procedural Haematoma	2/1389 (0.1%)		5/1378 (0.4%)
Shunt Occlusion	2/1389 (0.1%)		5/1378 (0.4%)
Subdural Haematoma	5/1389 (0.4%)		3/1378 (0.2%)
Wound	5/1389 (0.4%)		2/1378 (0.1%)
Arteriovenous Fistula Site Haematoma	4/1389 (0.3%)		4/1378 (0.3%)
Spinal Fracture	4/1389 (0.3%)		1/1378 (0.1%)
Arteriovenous Graft Aneurysm	1/1389 (0.1%)		3/1378 (0.2%)
Lower Limb Fracture	1/1389 (0.1%)		3/1378 (0.2%)
Wrist Fracture	0/1389 (0%)		3/1378 (0.2%)
Ankle Fracture	3/1389 (0.2%)		1/1378 (0.1%)
Hand Fracture	3/1389 (0.2%)		1/1378 (0.1%)
Post-Traumatic Pain	3/1389 (0.2%)		2/1378 (0.1%)
Pubic Rami Fracture	3/1389 (0.2%)		2/1378 (0.1%)
Spinal Compression Fracture	3/1389 (0.2%)		2/1378 (0.1%)
Tendon Rupture	3/1389 (0.2%)		1/1378 (0.1%)
Arteriovenous Graft Site Haemorrhage	0/1389 (0%)		2/1378 (0.1%)
Complications Of Transplanted Kidney	0/1389 (0%)		2/1378 (0.1%)
Foot Fracture	1/1389 (0.1%)		2/1378 (0.1%)
Head Injury	2/1389 (0.1%)		2/1378 (0.1%)
Incisional Hernia	0/1389 (0%)		2/1378 (0.1%)
Joint Dislocation	1/1389 (0.1%)		2/1378 (0.1%)
Procedural Pain	2/1389 (0.1%)		2/1378 (0.1%)
Shunt Malfunction	2/1389 (0.1%)		2/1378 (0.1%)
Therapeutic Agent Toxicity	2/1389 (0.1%)		2/1378 (0.1%)
Thoracic Vertebral Fracture	0/1389 (0%)		2/1378 (0.1%)
Tibia Fracture	2/1389 (0.1%)		2/1378 (0.1%)
Traumatic Haematoma	0/1389 (0%)		2/1378 (0.1%)
Upper Limb Fracture	1/1389 (0.1%)		2/1378 (0.1%)
Vascular Procedure Complication	1/1389 (0.1%)		2/1378 (0.1%)
Vascular Pseudoaneurysm	1/1389 (0.1%)		2/1378 (0.1%)
Accidental Overdose	2/1389 (0.1%)		0/1378 (0%)
Arteriovenous Graft Site Haematoma	2/1389 (0.1%)		1/1378 (0.1%)
Concussion	2/1389 (0.1%)		0/1378 (0%)
Dialysis Device Complication	2/1389 (0.1%)		1/1378 (0.1%)
Injury	2/1389 (0.1%)		1/1378 (0.1%)
Postoperative Wound Complication	2/1389 (0.1%)		1/1378 (0.1%)
Radius Fracture	2/1389 (0.1%)		1/1378 (0.1%)
Road Traffic Accident	2/1389 (0.1%)		1/1378 (0.1%)
Acetabulum Fracture	1/1389 (0.1%)		1/1378 (0.1%)
Alcohol Poisoning	0/1389 (0%)		1/1378 (0.1%)
Cerebral Haemorrhage Traumatic	0/1389 (0%)		1/1378 (0.1%)
Cervical Vertebral Fracture	0/1389 (0%)		1/1378 (0.1%)
Chest Injury	0/1389 (0%)		1/1378 (0.1%)
Clavicle Fracture	0/1389 (0%)		1/1378 (0.1%)
Extrusion Of Device	0/1389 (0%)		1/1378 (0.1%)
Foreign Body Trauma	0/1389 (0%)		1/1378 (0.1%)
Graft Complication	1/1389 (0.1%)		1/1378 (0.1%)
Graft Haemorrhage	0/1389 (0%)		1/1378 (0.1%)
Heat Illness	0/1389 (0%)		1/1378 (0.1%)
Joint Injury	1/1389 (0.1%)		1/1378 (0.1%)
Limb Injury	1/1389 (0.1%)		1/1378 (0.1%)
Medical Device Complication	1/1389 (0.1%)		1/1378 (0.1%)
Medical Device Pain	0/1389 (0%)		1/1378 (0.1%)
Multiple Fractures	0/1389 (0%)		1/1378 (0.1%)
Multiple Injuries	1/1389 (0.1%)		1/1378 (0.1%)
Muscle Strain	0/1389 (0%)		1/1378 (0.1%)
Narcotic Intoxication	0/1389 (0%)		1/1378 (0.1%)
Overdose	1/1389 (0.1%)		1/1378 (0.1%)
Patella Fracture	0/1389 (0%)		1/1378 (0.1%)
Periorbital Haematoma	0/1389 (0%)		1/1378 (0.1%)
Perirenal Haematoma	0/1389 (0%)		1/1378 (0.1%)
Post Procedural Fistula	0/1389 (0%)		1/1378 (0.1%)
Shunt Aneurysm	0/1389 (0%)		1/1378 (0.1%)
Skeletal Injury	0/1389 (0%)		1/1378 (0.1%)
Skin Laceration	0/1389 (0%)		1/1378 (0.1%)
Sternal Fracture	0/1389 (0%)		1/1378 (0.1%)
Thermal Burn	1/1389 (0.1%)		1/1378 (0.1%)
Wound Dehiscence	0/1389 (0%)		1/1378 (0.1%)
Anaemia Postoperative	1/1389 (0.1%)		0/1378 (0%)
Arterial Injury	1/1389 (0.1%)		0/1378 (0%)
Cardiac Pacemaker Malfunction	1/1389 (0.1%)		0/1378 (0%)
Cardiac Procedure Complication	1/1389 (0.1%)		0/1378 (0%)
Collapse Of Lung	1/1389 (0.1%)		0/1378 (0%)
Comminuted Fracture	1/1389 (0.1%)		0/1378 (0%)
Dialysis Disequilibrium Syndrome	1/1389 (0.1%)		0/1378 (0%)
Dislocation Of Joint Prosthesis	1/1389 (0.1%)		0/1378 (0%)
Dislocation Of Vertebra	1/1389 (0.1%)		0/1378 (0%)
Drug Toxicity	1/1389 (0.1%)		0/1378 (0%)
Facial Bones Fracture	1/1389 (0.1%)		0/1378 (0%)
Fractured Sacrum	1/1389 (0.1%)		0/1378 (0%)
Haemolytic Transfusion Reaction	1/1389 (0.1%)		0/1378 (0%)
Ilium Fracture	1/1389 (0.1%)		0/1378 (0%)
Lumbar Vertebral Fracture	1/1389 (0.1%)		0/1378 (0%)
Operative Haemorrhage	1/1389 (0.1%)		0/1378 (0%)
Pacemaker Complication	1/1389 (0.1%)		0/1378 (0%)
Peripheral Nerve Injury	1/1389 (0.1%)		0/1378 (0%)
Procedural Vomiting	1/1389 (0.1%)		0/1378 (0%)
Skull Fracture	1/1389 (0.1%)		0/1378 (0%)
Stent-Graft Endoleak	1/1389 (0.1%)		0/1378 (0%)
Subdural Haemorrhage	1/1389 (0.1%)		0/1378 (0%)
Suture Related Complication	1/1389 (0.1%)		0/1378 (0%)
Transfusion Reaction	1/1389 (0.1%)		0/1378 (0%)
Traumatic Brain Injury	1/1389 (0.1%)		0/1378 (0%)
Traumatic Intracranial Haemorrhage	1/1389 (0.1%)		0/1378 (0%)
Vascular Injury	1/1389 (0.1%)		0/1378 (0%)
Venous Injury	1/1389 (0.1%)		0/1378 (0%)
Weight Decreased	1/1389 (0.1%)		4/1378 (0.3%)
International Normalised Ratio Increased	0/1389 (0%)		2/1378 (0.1%)
Blood Calcium Decreased	2/1389 (0.1%)		0/1378 (0%)
Blood Pressure Increased	2/1389 (0.1%)		0/1378 (0%)
Blood Glucose Increased	0/1389 (0%)		1/1378 (0.1%)
C-Reactive Protein Increased	1/1389 (0.1%)		1/1378 (0.1%)
Electrocardiogram Q Wave Abnormal	0/1389 (0%)		1/1378 (0.1%)
Electrocardiogram T Wave Inversion	0/1389 (0%)		1/1378 (0.1%)
Occult Blood Positive	0/1389 (0%)		1/1378 (0.1%)
Urine Cytology Abnormal	0/1389 (0%)		1/1378 (0.1%)
Alanine Aminotransferase Increased	1/1389 (0.1%)		0/1378 (0%)
Blood Creatinine Increased	1/1389 (0.1%)		0/1378 (0%)
Blood Culture Positive	1/1389 (0.1%)		0/1378 (0%)
Blood Potassium Increased	1/1389 (0.1%)		0/1378 (0%)
Electrocardiogram T Wave Amplitude Increased	1/1389 (0.1%)		0/1378 (0%)
Haemoglobin Decreased	1/1389 (0.1%)		0/1378 (0%)
Liver Function Test Abnormal	1/1389 (0.1%)		0/1378 (0%)
Metabolism and nutrition disorders
Hyperkalaemia	7/1389 (0.5%)		13/1378 (0.9%)
Diabetic Foot	3/1389 (0.2%)		12/1378 (0.9%)
Fluid Overload	7/1389 (0.5%)		10/1378 (0.7%)
Hypoglycaemia	7/1389 (0.5%)		8/1378 (0.6%)
Fluid Retention	8/1389 (0.6%)		6/1378 (0.4%)
Dehydration	4/1389 (0.3%)		1/1378 (0.1%)
Calciphylaxis	3/1389 (0.2%)		3/1378 (0.2%)
Malnutrition	2/1389 (0.1%)		3/1378 (0.2%)
Diabetes Mellitus	3/1389 (0.2%)		2/1378 (0.1%)
Hyperglycaemia	3/1389 (0.2%)		0/1378 (0%)
Cachexia	2/1389 (0.1%)		2/1378 (0.1%)
Hyperphosphataemia	1/1389 (0.1%)		2/1378 (0.1%)
Hypokalaemia	1/1389 (0.1%)		2/1378 (0.1%)
Hypervolaemia	2/1389 (0.1%)		0/1378 (0%)
Metabolic Acidosis	2/1389 (0.1%)		1/1378 (0.1%)
Anorexia	1/1389 (0.1%)		1/1378 (0.1%)
Diabetes Mellitus Inadequate Control	1/1389 (0.1%)		1/1378 (0.1%)
Diabetic Ketoacidosis	0/1389 (0%)		1/1378 (0.1%)
Gout	1/1389 (0.1%)		1/1378 (0.1%)
Hypocalcaemia	0/1389 (0%)		1/1378 (0.1%)
Hypovolaemia	0/1389 (0%)		1/1378 (0.1%)
Hypercalcaemia	1/1389 (0.1%)		0/1378 (0%)
Metabolic Disorder	1/1389 (0.1%)		0/1378 (0%)
Musculoskeletal and connective tissue disorders
Osteoarthritis	8/1389 (0.6%)		5/1378 (0.4%)
Arthralgia	5/1389 (0.4%)		7/1378 (0.5%)
Arthritis	1/1389 (0.1%)		7/1378 (0.5%)
Back Pain	7/1389 (0.5%)		7/1378 (0.5%)
Musculoskeletal Chest Pain	2/1389 (0.1%)		4/1378 (0.3%)
Neck Pain	4/1389 (0.3%)		0/1378 (0%)
Pain In Extremity	4/1389 (0.3%)		3/1378 (0.2%)
Muscle Haemorrhage	1/1389 (0.1%)		3/1378 (0.2%)
Muscular Weakness	1/1389 (0.1%)		3/1378 (0.2%)
Osteitis	2/1389 (0.1%)		3/1378 (0.2%)
Bursitis	3/1389 (0.2%)		1/1378 (0.1%)
Spinal Osteoarthritis	3/1389 (0.2%)		0/1378 (0%)
Bone Pain	1/1389 (0.1%)		2/1378 (0.1%)
Chondrocalcinosis Pyrophosphate	0/1389 (0%)		2/1378 (0.1%)
Intervertebral Disc Protrusion	2/1389 (0.1%)		0/1378 (0%)
Lumbar Spinal Stenosis	2/1389 (0.1%)		1/1378 (0.1%)
Muscle Spasms	0/1389 (0%)		1/1378 (0.1%)
Musculoskeletal Pain	0/1389 (0%)		1/1378 (0.1%)
Myalgia	1/1389 (0.1%)		1/1378 (0.1%)
Osteonecrosis	0/1389 (0%)		1/1378 (0.1%)
Osteoporosis	0/1389 (0%)		1/1378 (0.1%)
Polymyalgia Rheumatica	0/1389 (0%)		1/1378 (0.1%)
Rhabdomyolysis	0/1389 (0%)		1/1378 (0.1%)
Soft Tissue Haemorrhage	0/1389 (0%)		1/1378 (0.1%)
Synovial Cyst	0/1389 (0%)		1/1378 (0.1%)
Tenosynovitis	0/1389 (0%)		1/1378 (0.1%)
Trigger Finger	0/1389 (0%)		1/1378 (0.1%)
Bone Cyst	1/1389 (0.1%)		0/1378 (0%)
Dupuytren's Contracture	1/1389 (0.1%)		0/1378 (0%)
Intervertebral Disc Space Narrowing	1/1389 (0.1%)		0/1378 (0%)
Joint Swelling	1/1389 (0.1%)		0/1378 (0%)
Monarthritis	1/1389 (0.1%)		0/1378 (0%)
Nodal Osteoarthritis	1/1389 (0.1%)		0/1378 (0%)
Osteitis Deformans	1/1389 (0.1%)		0/1378 (0%)
Psoriatic Arthropathy	1/1389 (0.1%)		0/1378 (0%)
Synovitis	1/1389 (0.1%)		0/1378 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer	3/1389 (0.2%)		7/1378 (0.5%)
Bladder Cancer	1/1389 (0.1%)		4/1378 (0.3%)
Colon Cancer	2/1389 (0.1%)		4/1378 (0.3%)
Lung Neoplasm Malignant	4/1389 (0.3%)		4/1378 (0.3%)
Renal Cell Carcinoma	0/1389 (0%)		4/1378 (0.3%)
Metastases To Liver	4/1389 (0.3%)		1/1378 (0.1%)
Parathyroid Tumour Benign	4/1389 (0.3%)		0/1378 (0%)
Breast Cancer	3/1389 (0.2%)		1/1378 (0.1%)
Gastric Cancer	3/1389 (0.2%)		0/1378 (0%)
Metastases To Lung	3/1389 (0.2%)		0/1378 (0%)
Oesophageal Carcinoma	0/1389 (0%)		2/1378 (0.1%)
Plasmacytoma	0/1389 (0%)		2/1378 (0.1%)
Rectal Cancer	1/1389 (0.1%)		2/1378 (0.1%)
Skin Cancer	0/1389 (0%)		2/1378 (0.1%)
Squamous Cell Carcinoma Of Skin	0/1389 (0%)		2/1378 (0.1%)
Hepatic Neoplasm Malignant	2/1389 (0.1%)		0/1378 (0%)
Lip Neoplasm Malignant Stage Unspecified	2/1389 (0.1%)		0/1378 (0%)
Lung Neoplasm	2/1389 (0.1%)		1/1378 (0.1%)
Rectosigmoid Cancer	2/1389 (0.1%)		0/1378 (0%)
Renal Cancer	2/1389 (0.1%)		1/1378 (0.1%)
Basal Cell Carcinoma	1/1389 (0.1%)		1/1378 (0.1%)
Bile Duct Cancer	0/1389 (0%)		1/1378 (0.1%)
Bladder Transitional Cell Carcinoma Stage Iii	0/1389 (0%)		1/1378 (0.1%)
Cervix Carcinoma	0/1389 (0%)		1/1378 (0.1%)
Colon Adenoma	1/1389 (0.1%)		1/1378 (0.1%)
Colon Cancer Metastatic	0/1389 (0%)		1/1378 (0.1%)
Epiglottic Carcinoma	0/1389 (0%)		1/1378 (0.1%)
Gallbladder Cancer Metastatic	0/1389 (0%)		1/1378 (0.1%)
Gastrointestinal Carcinoma	1/1389 (0.1%)		1/1378 (0.1%)
Laryngeal Cancer	0/1389 (0%)		1/1378 (0.1%)
Laryngeal Cancer Stage Iii	0/1389 (0%)		1/1378 (0.1%)
Leiomyosarcoma	0/1389 (0%)		1/1378 (0.1%)
Lymphoma	1/1389 (0.1%)		1/1378 (0.1%)
Malignant Melanoma	0/1389 (0%)		1/1378 (0.1%)
Metastasis	0/1389 (0%)		1/1378 (0.1%)
Metastatic Malignant Melanoma	0/1389 (0%)		1/1378 (0.1%)
Metastatic Pain	0/1389 (0%)		1/1378 (0.1%)
Metastatic Renal Cell Carcinoma	0/1389 (0%)		1/1378 (0.1%)
Non-Hodgkin's Lymphoma	0/1389 (0%)		1/1378 (0.1%)
Prostate Cancer Metastatic	0/1389 (0%)		1/1378 (0.1%)
Prostatic Adenoma	1/1389 (0.1%)		1/1378 (0.1%)
Renal Oncocytoma	0/1389 (0%)		1/1378 (0.1%)
Thyroid Cancer	1/1389 (0.1%)		1/1378 (0.1%)
Uterine Cancer	0/1389 (0%)		1/1378 (0.1%)
Benign Breast Neoplasm	1/1389 (0.1%)		0/1378 (0%)
Benign Lung Neoplasm	1/1389 (0.1%)		0/1378 (0%)
Benign Neoplasm Of Testis	1/1389 (0.1%)		0/1378 (0%)
Benign Small Intestinal Neoplasm	1/1389 (0.1%)		0/1378 (0%)
Bladder Papilloma	1/1389 (0.1%)		0/1378 (0%)
Bone Neoplasm	1/1389 (0.1%)		0/1378 (0%)
Brain Neoplasm	1/1389 (0.1%)		0/1378 (0%)
Breast Cancer Female	1/1389 (0.1%)		0/1378 (0%)
Carcinoid Tumour Of The Stomach	1/1389 (0.1%)		0/1378 (0%)
Choroid Melanoma	1/1389 (0.1%)		0/1378 (0%)
Colon Cancer Stage I	1/1389 (0.1%)		0/1378 (0%)
Follicle Centre Lymphoma, Follicular Grade I, Ii, Iii Stage I	1/1389 (0.1%)		0/1378 (0%)
Gastrointestinal Tract Adenoma	1/1389 (0.1%)		0/1378 (0%)
Liposarcoma	1/1389 (0.1%)		0/1378 (0%)
Lung Adenocarcinoma	1/1389 (0.1%)		0/1378 (0%)
Lung Squamous Cell Carcinoma Stage Unspecified	1/1389 (0.1%)		0/1378 (0%)
Lymphocytic Lymphoma	1/1389 (0.1%)		0/1378 (0%)
Metastases To Central Nervous System	1/1389 (0.1%)		0/1378 (0%)
Metastatic Carcinoma Of The Bladder	1/1389 (0.1%)		0/1378 (0%)
Metastatic Neoplasm	1/1389 (0.1%)		0/1378 (0%)
Multiple Myeloma	1/1389 (0.1%)		0/1378 (0%)
Non-Small Cell Lung Cancer	1/1389 (0.1%)		0/1378 (0%)
Ovarian Cancer	1/1389 (0.1%)		0/1378 (0%)
Pancreatic Carcinoma Metastatic	1/1389 (0.1%)		0/1378 (0%)
Rectal Cancer Metastatic	1/1389 (0.1%)		0/1378 (0%)
Rectal Cancer Recurrent	1/1389 (0.1%)		0/1378 (0%)
Squamous Cell Carcinoma	1/1389 (0.1%)		0/1378 (0%)
Tongue Neoplasm Malignant Stage Unspecified	1/1389 (0.1%)		0/1378 (0%)
Nervous system disorders
Convulsion	6/1389 (0.4%)		2/1378 (0.1%)
Cerebrovascular Accident	30/1389 (2.2%)		29/1378 (2.1%)
Carpal Tunnel Syndrome	10/1389 (0.7%)		10/1378 (0.7%)
Syncope	10/1389 (0.7%)		7/1378 (0.5%)
Haemorrhagic Stroke	9/1389 (0.6%)		1/1378 (0.1%)
Cerebral Haemorrhage	6/1389 (0.4%)		8/1378 (0.6%)
Ischaemic Stroke	6/1389 (0.4%)		8/1378 (0.6%)
Cerebral Infarction	2/1389 (0.1%)		5/1378 (0.4%)
Carotid Artery Stenosis	4/1389 (0.3%)		0/1378 (0%)
Epilepsy	2/1389 (0.1%)		3/1378 (0.2%)
Subarachnoid Haemorrhage	3/1389 (0.2%)		3/1378 (0.2%)
Headache	3/1389 (0.2%)		1/1378 (0.1%)
Dizziness	1/1389 (0.1%)		2/1378 (0.1%)
Dysarthria	2/1389 (0.1%)		2/1378 (0.1%)
Haemorrhage Intracranial	2/1389 (0.1%)		2/1378 (0.1%)
Hypoglycaemic Coma	0/1389 (0%)		2/1378 (0.1%)
Loss Of Consciousness	1/1389 (0.1%)		2/1378 (0.1%)
Sciatica	2/1389 (0.1%)		2/1378 (0.1%)
Somnolence	1/1389 (0.1%)		2/1378 (0.1%)
Vertebrobasilar Insufficiency	0/1389 (0%)		2/1378 (0.1%)
Carotid Arteriosclerosis	2/1389 (0.1%)		0/1378 (0%)
Cerebellar Haemorrhage	2/1389 (0.1%)		1/1378 (0.1%)
Coma	2/1389 (0.1%)		1/1378 (0.1%)
Dementia	2/1389 (0.1%)		0/1378 (0%)
Depressed Level Of Consciousness	2/1389 (0.1%)		0/1378 (0%)
Grand Mal Convulsion	2/1389 (0.1%)		1/1378 (0.1%)
Hypertensive Encephalopathy	2/1389 (0.1%)		1/1378 (0.1%)
Uraemic Encephalopathy	2/1389 (0.1%)		0/1378 (0%)
Balance Disorder	0/1389 (0%)		1/1378 (0.1%)
Brain Oedema	0/1389 (0%)		1/1378 (0.1%)
Cerebral Arteriosclerosis	0/1389 (0%)		1/1378 (0.1%)
Cerebral Artery Thrombosis	0/1389 (0%)		1/1378 (0.1%)
Cerebral Ischaemia	1/1389 (0.1%)		1/1378 (0.1%)
Cerebrovascular Disorder	0/1389 (0%)		1/1378 (0.1%)
Cervical Cord Compression	0/1389 (0%)		1/1378 (0.1%)
Cognitive Disorder	0/1389 (0%)		1/1378 (0.1%)
Coma Hepatic	0/1389 (0%)		1/1378 (0.1%)
Coma Uraemic	0/1389 (0%)		1/1378 (0.1%)
Demyelination	0/1389 (0%)		1/1378 (0.1%)
Diabetic Neuropathy	0/1389 (0%)		1/1378 (0.1%)
Encephalopathy	1/1389 (0.1%)		1/1378 (0.1%)
Hemiplegia	0/1389 (0%)		1/1378 (0.1%)
Lacunar Infarction	0/1389 (0%)		1/1378 (0.1%)
Memory Impairment	0/1389 (0%)		1/1378 (0.1%)
Nervous System Disorder	1/1389 (0.1%)		1/1378 (0.1%)
Neuralgia	1/1389 (0.1%)		1/1378 (0.1%)
Neurodegenerative Disorder	0/1389 (0%)		1/1378 (0.1%)
Peripheral Motor Neuropathy	0/1389 (0%)		1/1378 (0.1%)
Spondylitic Myelopathy	0/1389 (0%)		1/1378 (0.1%)
Status Epilepticus	0/1389 (0%)		1/1378 (0.1%)
Stupor	1/1389 (0.1%)		1/1378 (0.1%)
Altered State Of Consciousness	1/1389 (0.1%)		0/1378 (0%)
Amnesia	1/1389 (0.1%)		0/1378 (0%)
Anoxic Encephalopathy	1/1389 (0.1%)		0/1378 (0%)
Arachnoid Cyst	1/1389 (0.1%)		0/1378 (0%)
Brain Compression	1/1389 (0.1%)		0/1378 (0%)
Cerebral Disorder	1/1389 (0.1%)		0/1378 (0%)
Diabetic Autonomic Neuropathy	1/1389 (0.1%)		0/1378 (0%)
Guillain-Barre Syndrome	1/1389 (0.1%)		0/1378 (0%)
Hemiparesis	1/1389 (0.1%)		0/1378 (0%)
Hydrocephalus	1/1389 (0.1%)		0/1378 (0%)
Hypoaesthesia	1/1389 (0.1%)		0/1378 (0%)
Intercostal Neuralgia	1/1389 (0.1%)		0/1378 (0%)
Intracranial Aneurysm	1/1389 (0.1%)		0/1378 (0%)
Intracranial Haematoma	1/1389 (0.1%)		0/1378 (0%)
Intraventricular Haemorrhage	1/1389 (0.1%)		0/1378 (0%)
Metabolic Encephalopathy	1/1389 (0.1%)		0/1378 (0%)
Monoparesis	1/1389 (0.1%)		0/1378 (0%)
Neuropathy Peripheral	1/1389 (0.1%)		0/1378 (0%)
Parkinson's Disease	1/1389 (0.1%)		0/1378 (0%)
Presenile Dementia	1/1389 (0.1%)		0/1378 (0%)
Quadriparesis	1/1389 (0.1%)		0/1378 (0%)
Restless Legs Syndrome	1/1389 (0.1%)		0/1378 (0%)
Simple Partial Seizures	1/1389 (0.1%)		0/1378 (0%)
Vascular Dementia	1/1389 (0.1%)		0/1378 (0%)
Vascular Encephalopathy	1/1389 (0.1%)		0/1378 (0%)
Psychiatric disorders
Confusional State	6/1389 (0.4%)		10/1378 (0.7%)
Delirium	2/1389 (0.1%)		2/1378 (0.1%)
Sleep Disorder	2/1389 (0.1%)		0/1378 (0%)
Alcohol Abuse	0/1389 (0%)		1/1378 (0.1%)
Anxiety	1/1389 (0.1%)		1/1378 (0.1%)
Completed Suicide	0/1389 (0%)		1/1378 (0.1%)
Depression	0/1389 (0%)		1/1378 (0.1%)
Disorientation	1/1389 (0.1%)		1/1378 (0.1%)
Impaired Self-Care	0/1389 (0%)		1/1378 (0.1%)
Psychotic Disorder	1/1389 (0.1%)		1/1378 (0.1%)
Delusional Disorder, Persecutory Type	1/1389 (0.1%)		0/1378 (0%)
Insomnia	1/1389 (0.1%)		0/1378 (0%)
Mental Disorder	1/1389 (0.1%)		0/1378 (0%)
Psychotic Disorder Due To A General Medical Condition	1/1389 (0.1%)		0/1378 (0%)
Renal and urinary disorders
Renal Failure Chronic	8/1389 (0.6%)		9/1378 (0.7%)
Haematuria	5/1389 (0.4%)		8/1378 (0.6%)
Azotaemia	3/1389 (0.2%)		4/1378 (0.3%)
Renal Haemorrhage	3/1389 (0.2%)		1/1378 (0.1%)
Renal Colic	0/1389 (0%)		2/1378 (0.1%)
Renal Failure	2/1389 (0.1%)		2/1378 (0.1%)
Calculus Bladder	2/1389 (0.1%)		0/1378 (0%)
Renal Cyst	2/1389 (0.1%)		1/1378 (0.1%)
Dysuria	0/1389 (0%)		1/1378 (0.1%)
Extravasation Of Urine	0/1389 (0%)		1/1378 (0.1%)
Hypertonic Bladder	1/1389 (0.1%)		1/1378 (0.1%)
Pyuria	0/1389 (0%)		1/1378 (0.1%)
Renal Artery Stenosis	0/1389 (0%)		1/1378 (0.1%)
Ureteric Obstruction	0/1389 (0%)		1/1378 (0.1%)
Urinary Retention	0/1389 (0%)		1/1378 (0.1%)
Calculus Urethral	1/1389 (0.1%)		0/1378 (0%)
Cystitis Haemorrhagic	1/1389 (0.1%)		0/1378 (0%)
Hydronephrosis	1/1389 (0.1%)		0/1378 (0%)
Nephrolithiasis	1/1389 (0.1%)		0/1378 (0%)
Renal Cyst Ruptured	1/1389 (0.1%)		0/1378 (0%)
Urethral Stenosis	1/1389 (0.1%)		0/1378 (0%)
Urinary Bladder Haemorrhage	1/1389 (0.1%)		0/1378 (0%)
Reproductive system and breast disorders
Metrorrhagia	0/1389 (0%)		2/1378 (0.1%)
Prostatism	2/1389 (0.1%)		0/1378 (0%)
Prostatomegaly	2/1389 (0.1%)		0/1378 (0%)
Benign Prostatic Hyperplasia	1/1389 (0.1%)		1/1378 (0.1%)
Endometrial Hypertrophy	0/1389 (0%)		1/1378 (0.1%)
Menorrhagia	0/1389 (0%)		1/1378 (0.1%)
Ovarian Cyst	1/1389 (0.1%)		1/1378 (0.1%)
Pelvic Pain	0/1389 (0%)		1/1378 (0.1%)
Prostatitis	1/1389 (0.1%)		1/1378 (0.1%)
Uterine Prolapse	0/1389 (0%)		1/1378 (0.1%)
Balanitis	1/1389 (0.1%)		0/1378 (0%)
Dysfunctional Uterine Bleeding	1/1389 (0.1%)		0/1378 (0%)
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema	13/1389 (0.9%)		25/1378 (1.8%)
Dyspnoea	19/1389 (1.4%)		22/1378 (1.6%)
Acute Pulmonary Oedema	6/1389 (0.4%)		18/1378 (1.3%)
Chronic Obstructive Pulmonary Disease	4/1389 (0.3%)		14/1378 (1%)
Pleural Effusion	7/1389 (0.5%)		11/1378 (0.8%)
Epistaxis	7/1389 (0.5%)		3/1378 (0.2%)
Respiratory Failure	4/1389 (0.3%)		6/1378 (0.4%)
Pleurisy	6/1389 (0.4%)		2/1378 (0.1%)
Pulmonary Embolism	6/1389 (0.4%)		5/1378 (0.4%)
Acute Respiratory Failure	0/1389 (0%)		4/1378 (0.3%)
Hydrothorax	2/1389 (0.1%)		4/1378 (0.3%)
Haemothorax	4/1389 (0.3%)		3/1378 (0.2%)
Haemoptysis	1/1389 (0.1%)		3/1378 (0.2%)
Pneumonia Aspiration	3/1389 (0.2%)		3/1378 (0.2%)
Pneumothorax	0/1389 (0%)		2/1378 (0.1%)
Respiratory Arrest	1/1389 (0.1%)		2/1378 (0.1%)
Respiratory Distress	0/1389 (0%)		2/1378 (0.1%)
Bronchitis Chronic	2/1389 (0.1%)		1/1378 (0.1%)
Foreign Body Aspiration	2/1389 (0.1%)		0/1378 (0%)
Hypoxia	2/1389 (0.1%)		0/1378 (0%)
Pulmonary Congestion	2/1389 (0.1%)		0/1378 (0%)
Pulmonary Hypertension	2/1389 (0.1%)		0/1378 (0%)
Asthma	0/1389 (0%)		1/1378 (0.1%)
Atelectasis	0/1389 (0%)		1/1378 (0.1%)
Bronchial Fistula	0/1389 (0%)		1/1378 (0.1%)
Hydropneumothorax	0/1389 (0%)		1/1378 (0.1%)
Lung Consolidation	0/1389 (0%)		1/1378 (0.1%)
Pulmonary Fibrosis	1/1389 (0.1%)		1/1378 (0.1%)
Respiratory Acidosis	0/1389 (0%)		1/1378 (0.1%)
Sleep Apnoea Syndrome	1/1389 (0.1%)		1/1378 (0.1%)
Tachypnoea	0/1389 (0%)		1/1378 (0.1%)
Aspiration	1/1389 (0.1%)		0/1378 (0%)
Bronchospasm	1/1389 (0.1%)		0/1378 (0%)
Cough	1/1389 (0.1%)		0/1378 (0%)
Dyspnoea Exertional	1/1389 (0.1%)		0/1378 (0%)
Hiccups	1/1389 (0.1%)		0/1378 (0%)
Lung Infiltration	1/1389 (0.1%)		0/1378 (0%)
Pneumonitis	1/1389 (0.1%)		0/1378 (0%)
Productive Cough	1/1389 (0.1%)		0/1378 (0%)
Pulmonary Necrosis	1/1389 (0.1%)		0/1378 (0%)
Wegener's Granulomatosis	1/1389 (0.1%)		0/1378 (0%)
Skin and subcutaneous tissue disorders
Skin Ulcer	11/1389 (0.8%)		10/1378 (0.7%)
Skin Necrosis	2/1389 (0.1%)		2/1378 (0.1%)
Diabetic Ulcer	2/1389 (0.1%)		1/1378 (0.1%)
Cutaneous Vasculitis	0/1389 (0%)		1/1378 (0.1%)
Dermatitis Exfoliative	0/1389 (0%)		1/1378 (0.1%)
Ingrowing Nail	0/1389 (0%)		1/1378 (0.1%)
Pemphigus	0/1389 (0%)		1/1378 (0.1%)
Dermatitis Allergic	1/1389 (0.1%)		0/1378 (0%)
Dry Gangrene	1/1389 (0.1%)		0/1378 (0%)
Nail Discolouration	1/1389 (0.1%)		0/1378 (0%)
Vascular disorders
Refusal Of Treatment By Patient	0/1389 (0%)		1/1378 (0.1%)
Arterial Bypass Operation	0/1389 (0%)		1/1378 (0.1%)
Catheter Placement	0/1389 (0%)		1/1378 (0.1%)
Chemotherapy Neurotoxicity Attenuation	1/1389 (0.1%)		0/1378 (0%)
Parathyroidectomy	1/1389 (0.1%)		0/1378 (0%)
Peripheral Ischaemia	24/1389 (1.7%)		14/1378 (1%)
Hypotension	14/1389 (1%)		20/1378 (1.5%)
Peripheral Arterial Occlusive Disease	15/1389 (1.1%)		10/1378 (0.7%)
Hypertension	11/1389 (0.8%)		11/1378 (0.8%)
Peripheral Vascular Disorder	5/1389 (0.4%)		10/1378 (0.7%)
Hypertensive Crisis	8/1389 (0.6%)		6/1378 (0.4%)
Extremity Necrosis	7/1389 (0.5%)		4/1378 (0.3%)
Arteriosclerosis	5/1389 (0.4%)		6/1378 (0.4%)
Haematoma	6/1389 (0.4%)		3/1378 (0.2%)
Aortic Aneurysm	2/1389 (0.1%)		4/1378 (0.3%)
Arteritis	0/1389 (0%)		4/1378 (0.3%)
Aortic Aneurysm Rupture	1/1389 (0.1%)		3/1378 (0.2%)
Cardiovascular Insufficiency	1/1389 (0.1%)		3/1378 (0.2%)
Deep Vein Thrombosis	2/1389 (0.1%)		3/1378 (0.2%)
Femoral Artery Occlusion	0/1389 (0%)		3/1378 (0.2%)
Shock	1/1389 (0.1%)		3/1378 (0.2%)
Venous Stenosis	3/1389 (0.2%)		3/1378 (0.2%)
Aortic Stenosis	2/1389 (0.1%)		2/1378 (0.1%)
Circulatory Collapse	2/1389 (0.1%)		2/1378 (0.1%)
Intermittent Claudication	1/1389 (0.1%)		2/1378 (0.1%)
Peripheral Artery Aneurysm	0/1389 (0%)		2/1378 (0.1%)
Steal Syndrome	1/1389 (0.1%)		2/1378 (0.1%)
Superior Vena Caval Stenosis	1/1389 (0.1%)		2/1378 (0.1%)
Vena Cava Thrombosis	1/1389 (0.1%)		2/1378 (0.1%)
Venous Occlusion	0/1389 (0%)		2/1378 (0.1%)
Arterial Stenosis Limb	2/1389 (0.1%)		1/1378 (0.1%)
Femoral Arterial Stenosis	2/1389 (0.1%)		1/1378 (0.1%)
Hypovolaemic Shock	2/1389 (0.1%)		0/1378 (0%)
Iliac Artery Stenosis	2/1389 (0.1%)		1/1378 (0.1%)
Subclavian Artery Stenosis	2/1389 (0.1%)		0/1378 (0%)
Aneurysm	0/1389 (0%)		1/1378 (0.1%)
Aneurysm Ruptured	0/1389 (0%)		1/1378 (0.1%)
Aortic Dissection	0/1389 (0%)		1/1378 (0.1%)
Arterial Disorder	0/1389 (0%)		1/1378 (0.1%)
Arterial Stenosis	0/1389 (0%)		1/1378 (0.1%)
Arterial Thrombosis Limb	1/1389 (0.1%)		1/1378 (0.1%)
Arteriosclerosis Obliterans	1/1389 (0.1%)		1/1378 (0.1%)
Blue Toe Syndrome	0/1389 (0%)		1/1378 (0.1%)
Diabetic Vascular Disorder	0/1389 (0%)		1/1378 (0.1%)
Hypertensive Emergency	0/1389 (0%)		1/1378 (0.1%)
Iliac Artery Occlusion	0/1389 (0%)		1/1378 (0.1%)
Ischaemic Limb Pain	0/1389 (0%)		1/1378 (0.1%)
Lymphoedema	0/1389 (0%)		1/1378 (0.1%)
Necrosis Ischaemic	1/1389 (0.1%)		1/1378 (0.1%)
Poor Peripheral Circulation	1/1389 (0.1%)		1/1378 (0.1%)
Shock Haemorrhagic	1/1389 (0.1%)		1/1378 (0.1%)
Subclavian Vein Thrombosis	0/1389 (0%)		1/1378 (0.1%)
Thrombophlebitis	0/1389 (0%)		1/1378 (0.1%)
Vascular Calcification	0/1389 (0%)		1/1378 (0.1%)
Venous Aneurysm	0/1389 (0%)		1/1378 (0.1%)
Aortic Occlusion	1/1389 (0.1%)		0/1378 (0%)
Arterial Insufficiency	1/1389 (0.1%)		0/1378 (0%)
Lymphocele	1/1389 (0.1%)		0/1378 (0%)
Orthostatic Hypotension	1/1389 (0.1%)		0/1378 (0%)
Peripheral Embolism	1/1389 (0.1%)		0/1378 (0%)
Secondary Hypertension	1/1389 (0.1%)		0/1378 (0%)
Thrombophlebitis Superficial	1/1389 (0.1%)		0/1378 (0%)
Thrombosis	1/1389 (0.1%)		0/1378 (0%)
Vasculitis	1/1389 (0.1%)		0/1378 (0%)
Venous Thrombosis	1/1389 (0.1%)		0/1378 (0%)
Venous Thrombosis Limb	1/1389 (0.1%)		0/1378 (0%)
Other (Not Including Serious) Adverse Events
	Rosuvastatin 10mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	620/1389 (44.6%)		635/1378 (46.1%)
Blood and lymphatic system disorders
Anaemia	81/1389 (5.8%)		62/1378 (4.5%)
Cardiac disorders
Atrial Fibrillation	70/1389 (5%)		59/1378 (4.3%)
Gastrointestinal disorders
Diarrhoea	202/1389 (14.5%)		188/1378 (13.6%)
Vomiting	112/1389 (8.1%)		127/1378 (9.2%)
Nausea	121/1389 (8.7%)		97/1378 (7%)
Constipation	82/1389 (5.9%)		80/1378 (5.8%)
Abdominal Pain	80/1389 (5.8%)		74/1378 (5.4%)
Infections and infestations
Bronchitis	129/1389 (9.3%)		133/1378 (9.7%)
Nasopharyngitis	127/1389 (9.1%)		116/1378 (8.4%)
Urinary Tract Infection	92/1389 (6.6%)		83/1378 (6%)
Injury, poisoning and procedural complications
Arteriovenous Fistula Site Complication	131/1389 (9.4%)		131/1378 (9.5%)
Haemodialysis-Induced Symptom	79/1389 (5.7%)		78/1378 (5.7%)
Procedural Hypotension	76/1389 (5.5%)		75/1378 (5.4%)
Musculoskeletal and connective tissue disorders
Arthralgia	110/1389 (7.9%)		93/1378 (6.7%)
Muscle Spasms	90/1389 (6.5%)		101/1378 (7.3%)
Back Pain	97/1389 (7%)		92/1378 (6.7%)
Pain In Extremity	97/1389 (7%)		81/1378 (5.9%)
Nervous system disorders
Headache	109/1389 (7.8%)		112/1378 (8.1%)
Psychiatric disorders
Insomnia	68/1389 (4.9%)		77/1378 (5.6%)
Respiratory, thoracic and mediastinal disorders
Cough	120/1389 (8.6%)		125/1378 (9.1%)
Dyspnoea	102/1389 (7.3%)		99/1378 (7.2%)
Skin and subcutaneous tissue disorders
Pruritus	83/1389 (6%)		69/1378 (5%)
Vascular disorders
Hypotension	115/1389 (8.3%)		109/1378 (7.9%)
Hypertension	102/1389 (7.3%)		92/1378 (6.7%)

Limitations/Caveats

The endpoints were originally intended to be time to event endpoints, however we are unable to report the data as intended due to the nature of time to event endpoints. Therefore we have reported the number of participants who reached the event.

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.