Navigator: Long-term Study of Nateglinide+Valsartan to Prevent or Delay Type II Diabetes Mellitus and Cardiovascular Complications

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00097786
• Collaborator: (none)
• Enrollment: 9,306
• Locations: 38
• Arms: 4
• Duration (Months): 93
• Patients Per Site: 244.9
• Patients Per Site Per Month: 2.6

Study Details

Study Description

Brief Summary

This study is a test of the safety and effectiveness of two drugs, one for diabetes and one for hypertension, in keeping patients with high lab values of glucose from progressing to frank diabetes and developing cardiovascular complications. People in this study cannot have frank diabetes but are considered "borderline" based on blood tests. People in the study take none, one or both of the drugs and do not know which one(s) they are taking.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Valsartan 160 mg + nateglinide 60 mg; Drug: Valsartan 160 mg + nateglinide placebo; Drug: Nateglinide 60 mg + valsartan placebo; Drug: Valsartan placebo + nateglinide placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 9306 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: A Multinational, Randomized, Double-blind, Placebo-controlled, Forced-titration, 2 x 2 Factorial Design Study of the Efficacy and Safety of Long-term Administration of Nateglinide and Valsartan in the Prevention of Diabetes and Cardiovascular Outcomes in Subjects With Impaired Glucose Tolerance (IGT)
• Study Start Date: Jan 1, 2002
• Actual Primary Completion Date: Oct 1, 2009
• Actual Study Completion Date: Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Valsartan 160 mg + nateglinide 60 mg For the first 2 weeks of treatment, patients took the combination of nateglinide 30 mg (3 times daily, ante cibum [ac] before meals) and valsartan 80 mg (once daily [od] in the morning). After 2 weeks, patients were up-titrated to nateglinide 60 mg ac and valsartan 160 mg od.	Drug: Valsartan 160 mg + nateglinide 60 mg; The double-blinding of the randomized study medication was maintained by the use of identical placebo and active tablets and capsules for nateglinide and valsartan, respectively. Patients were instructed not to take the morning dose of either medication nor to eat breakfast on the day of a scheduled study visit, but to wait until after the visit was completed. Patients not tolerating the higher dose (Level 2) were down-titrated to receive Level 1. Patients not tolerating the lower dose (Level 1) had a treatment interruption. Starting at Week 2 and throughout the study, attempts were to be made to reach the highest dose level (Level 2), if medically acceptable. Following each change in dose level or re-initiation of treatment, tolerability was assessed after 2 weeks of exposure.
Experimental: Valsartan 160 mg + nateglinide placebo For the first 2 weeks of treatment, patients took valsartan 80 mg capsules (once daily [od] in the morning). After 2 weeks, patients were up-titrated to 160 mg valsartan od. Patients also received nateglinide placebo tablets (3 times daily, ante cibum [ac] before meals).	Drug: Valsartan 160 mg + nateglinide placebo; The double-blinding of the randomized study medication was maintained by the use of identical placebo and active tablets and capsules for nateglinide and valsartan, respectively. Patients were instructed not to take the morning dose of either medication nor to eat breakfast on the day of a scheduled study visit, but to wait until after the visit was completed. Patients not tolerating the higher dose (Level 2) were down-titrated to receive Level 1. Patients not tolerating the lower dose (Level 1) had a treatment interruption. Starting at Week 2 and throughout the study, attempts were to be made to reach the highest dose level (Level 2), if medically acceptable. Following each change in dose level or re-initiation of treatment, tolerability was assessed after 2 weeks of exposure.
Experimental: Nateglinide 60 mg + valsartan placebo For the first 2 weeks of treatment, patients took nateglinide 30 mg tablets (3 times daily, ante cibum [ac] before meals). After 2 weeks, patients were uptitrated to 60 mg nateglinide ac. Patients also received valsartan placebo capsules (once daily [od] in the morning).	Drug: Nateglinide 60 mg + valsartan placebo; The double-blinding of the randomized study medication was maintained by the use of identical placebo and active tablets and capsules for nateglinide and valsartan, respectively. Patients were instructed not to take the morning dose of either medication nor to eat breakfast on the day of a scheduled study visit, but to wait until after the visit was completed. Patients not tolerating the higher dose (Level 2) were down-titrated to receive Level 1. Patients not tolerating the lower dose (Level 1) had a treatment interruption. Starting at Week 2 and throughout the study, attempts were to be made to reach the highest dose level (Level 2), if medically acceptable. Following each change in dose level or re-initiation of treatment, tolerability was assessed after 2 weeks of exposure.
Placebo Comparator: Placebo Patients took 3 nateglinide placebo tablets (3 times daily, ante cibum [ac] before meals) and 1 valsartan placebo capsule (once daily [od] in the morning).	Drug: Valsartan placebo + nateglinide placebo; The double-blinding of the randomized study medication was maintained by the use of identical placebo and active tablets and capsules for nateglinide and valsartan, respectively. Patients were instructed not to take the morning dose of either medication nor to eat breakfast on the day of a scheduled study visit, but to wait until after the visit was completed. Patients not tolerating the higher dose (Level 2) were down-titrated to receive Level 1. Patients not tolerating the lower dose (Level 1) had a treatment interruption. Starting at Week 2 and throughout the study, attempts were to be made to reach the highest dose level (Level 2), if medically acceptable. Following each change in dose level or re-initiation of treatment, tolerability was assessed after 2 weeks of exposure.

Outcome Measures

Primary Outcome Measures

1. Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Valsartan Versus Non-valsartan [Mean patient duration of 4.2 years]

   Progression to diabetes was determined by (a) an algorithm based on central laboratory measurements of fasting plasma glucose and/or a 2 hour oral glucose tolerance test or (b) adjudication by the Diabetes Endpoint Adjudication Committee.

2. Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Valsartan Versus Non-valsartan [Mean patient duration of 5.6 years]

   The extended cardiovascular endpoint was defined as a cardiovascular morbidity/mortality event including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, revascularization procedure, hospitalization for congestive heart failure, and hospitalization for unstable angina.

3. Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Valsartan Versus Non-valsartan [Mean patient duration of 5.8 years]

   The core cardiovascular endpoint was defined as a cardiovascular morbidity/mortality event including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.

4. Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Nateglinide Versus Non-nateglinide [Mean patient duration of 4.2 years]

   Progression to diabetes was determined by (a) an algorithm based on central laboratory measurements of fasting plasma glucose and/or a 2 hour oral glucose tolerance test or (b) adjudication by the Diabetes Endpoint Adjudication Committee.

5. Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide [Mean patient duration of 5.6 years]

   The extended cardiovascular endpoint was defined as a cardiovascular morbidity/mortality event including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, revascularization procedure, hospitalization for congestive heart failure, and hospitalization for unstable angina.

6. Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide [Mean patient duration of 5.8 years]

   The core cardiovascular endpoint was defined as a cardiovascular morbidity/mortality event including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adults

• Impaired glucose tolerance

• Age dependent risk factors

Exclusion Criteria:

• Frank diabetes

For detailed information, call contact person.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Investigative Site	New Jersey	United States
2		Investigative Site		Argentina
3		Investigative Site		Australia
4		Investigative Sites		Austria
5		Investigative Site		Belgium
6		Investigative Site		Brazil
7		Investigative Site		Canada
8		Investigative Site		Chile
9		Investigative Site		China
10		Investigative Site		Colombia
11		Investigative Site		Czech Republic
12		Investigative Site		Denmark
13		Investigative Site		Ecuador
14		Investigative Site		Finland
15		Investigative Site		France
16		Investigative Site		Germany
17		Investigative Site		Greece
18		Investigative Site		Guatemala
19		Investigative Site		Hong Kong
20		Investigative Site		Hungary
21		Investigative Site		Italy
22		Investigative Site		Malaysia
23		Investigative Site		Mexico
24		Investigative Site		Netherlands
25		Investigative Site		Norway
26		Investigative Site		Peru
27		Investigative Site		Poland
28		Investigative Site		Russian Federation
29		Investigative Site		Singapore
30		Investigative Site		Slovakia
31		Investigative Site		South Africa
32		Investigative Site		Spain
33		Investigative Site		Sweden
34		Investigative Site		Switzerland
35		Investigative Site		Taiwan
36		Investigative Site		Turkey
37		Investigative Site		United Kingdom
38		Investigative Site		Uruguay

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00097786
• Other Study ID Numbers: CDJN608B2302
• First Posted: Dec 1, 2004
• Last Update Posted: Jun 29, 2011
• Last Verified: Jun 1, 2011

• Keywords provided by , ,: Prevention; Diabetes type 2; valsartan; nateglinide
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Nateglinide; Valsartan

Study Results

Participant Flow

Recruitment Details	Initially enrolled 9518, 212 excluded.

Arm/Group Title	Valsartan 160 mg od + Nateglinide 60 mg ac	Valsartan 160 mg od + Placebo Nateglinide	Nateglinide 60 mg ac + Placebo Valsartan	Placebo
Arm/Group Description	For the first 2 weeks of treatment, patients took the combination of nateglinide 30 mg (3 times daily ante cibum [ac, before meals]) and valsartan 80 mg (once daily [od] in the morning). After 2 weeks, patients were uptitrated to nateglinide 60 mg ac and valsartan 160 mg od.	For the first 2 weeks of treatment, patients took valsartan 80 mg once daily (od) once in the morning. After 2 weeks, patients were uptitrated to 160 mg valsartan od. Patient also received placebo matching nateglinide tablets identical to the active nateglinide tablets (ac, before meals).	For the first 2 weeks of treatment, patients took one 30 mg tablet of nateglinide with a glass of water 1-30 minutes before each main meal of the day, ie, 3 times daily ante cibum (ac, before meals). If a meal was missed, the patient was not to take a tablet. After 2 weeks, patients were uptitrated to 60 mg nateglinide ac. Patients also received placebo matching valsartan capsules identical to the active valsartan capsules.	Patients took 3 placebo tablets identical to nateglinide tablets 3 times daily ac and 1 placebo capsule identical to valsartan capsule once daily in the morning.
Period Title: Overall Study
STARTED	2316	2315	2329	2346
Complete FU for Progression to Diabetes	1709	1712	1734	1762
Complete Follow-up for Extended CV EPs	1969	1985	1987	2015
Complete Follow-up for Core CV EPs	1948	1963	1966	1988
COMPLETED	2020	2023	2016	2036
NOT COMPLETED	296	292	313	310

Baseline Characteristics

Arm/Group Title	Valsartan 160 mg od + Nateglinide 60 mg ac	Valsartan 160 mg od + Placebo Nateglinide	Nateglinide 60 mg ac + Placebo Valsartan	Placebo	Total
Arm/Group Description	For the first 2 weeks of treatment, patients took the combination of nateglinide 30 mg (3 times daily ante cibum [ac, before meals]) and valsartan 80 mg (once daily [od] in the morning). After 2 weeks, patients were uptitrated to nateglinide 60 mg ac and valsartan 160 mg od.	For the first 2 weeks of treatment, patients took valsartan 80 mg once daily (od) once in the morning. After 2 weeks, patients were uptitrated to 160 mg valsartan od. Patient also received placebo matching nateglinide tablets identical to the active nateglinide tablets (ac, before meals).	For the first 2 weeks of treatment, patients took one 30 mg tablet of nateglinide with a glass of water 1-30 minutes before each main meal of the day, ie, 3 times daily ante cibum (ac, before meals). If a meal was missed, the patient was not to take a tablet. After 2 weeks, patients were uptitrated to 60 mg nateglinide ac. Patients also received placebo matching valsartan capsules identical to the active valsartan capsules.	Patients took 3 placebo tablets identical to nateglinide tablets 3 times daily ac and 1 placebo capsule identical to valsartan capsule once daily in the morning.	Total of all reporting groups
Overall Participants	2316	2315	2329	2346	9306
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.7 (6.75)	63.7 (6.91)	63.8 (6.82)	63.9 (6.88)	63.8 (6.84)
Sex: Female, Male (Count of Participants)
Female	1174 50.7%	1140 49.2%	1194 51.3%	1203 51.3%	4711 50.6%
Male	1142 49.3%	1175 50.8%	1135 48.7%	1143 48.7%	4595 49.4%

Outcome Measures

1. Primary Outcome

Title	Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Valsartan Versus Non-valsartan
Description	Progression to diabetes was determined by (a) an algorithm based on central laboratory measurements of fasting plasma glucose and/or a 2 hour oral glucose tolerance test or (b) adjudication by the Diabetes Endpoint Adjudication Committee.
Time Frame	Mean patient duration of 4.2 years

Outcome Measure Data

Analysis Population Description

Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies.

Arm/Group Title	Valsartan	Non-valsartan
Arm/Group Description	All patients from the treatment arms (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) valsartan 160 mg od only.	All patients from the treatment arms (1) nateglinide 60 mg ac and (2) placebo.
Measure Participants	4631	4675
Number [Percentage of patients]	33.1	36.8

2. Primary Outcome

Title	Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Valsartan Versus Non-valsartan
Description	The extended cardiovascular endpoint was defined as a cardiovascular morbidity/mortality event including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, revascularization procedure, hospitalization for congestive heart failure, and hospitalization for unstable angina.
Time Frame	Mean patient duration of 5.6 years

Outcome Measure Data

Analysis Population Description

Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies.

Arm/Group Title	Valsartan	Non-valsartan
Arm/Group Description	All patients from the treatment arms (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) valsartan 160 mg od only.	All patients from the treatment arms (1) nateglinide 60 mg ac and (2) placebo.
Measure Participants	4631	4675
Number [Percentage of patients]	14.5	14.8

3. Primary Outcome

Title	Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Valsartan Versus Non-valsartan
Description	The core cardiovascular endpoint was defined as a cardiovascular morbidity/mortality event including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.
Time Frame	Mean patient duration of 5.8 years

Outcome Measure Data

Analysis Population Description

Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies.

Arm/Group Title	Valsartan	Non-valsartan
Arm/Group Description	All patients from the treatment arms (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) valsartan 160 mg od only.	All patients from the treatment arms (1) nateglinide 60 mg ac and (2) placebo.
Measure Participants	4631	4675
Number [Percentage of patients]	8.1	8.1

4. Primary Outcome

Title	Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Nateglinide Versus Non-nateglinide
Description	Progression to diabetes was determined by (a) an algorithm based on central laboratory measurements of fasting plasma glucose and/or a 2 hour oral glucose tolerance test or (b) adjudication by the Diabetes Endpoint Adjudication Committee.
Time Frame	Mean patient duration of 4.2 years

Outcome Measure Data

Analysis Population Description

Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies.

Arm/Group Title	Nateglinide	Non-nateglinide
Arm/Group Description	All patients from the treatment arm (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) nateglinide 60 mg ac only.	All patients from the treatment arms (1) valsartan 160 mg od and (2) placebo.
Measure Participants	4645	4661
Number [Percentage of patients]	36.0	33.9

5. Primary Outcome

Title	Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide
Description	The extended cardiovascular endpoint was defined as a cardiovascular morbidity/mortality event including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, revascularization procedure, hospitalization for congestive heart failure, and hospitalization for unstable angina.
Time Frame	Mean patient duration of 5.6 years

Outcome Measure Data

Analysis Population Description

Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies.

Arm/Group Title	Nateglinide	Non-nateglinide
Arm/Group Description	All patients from the treatment arm (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) nateglinide 60 mg ac only.	All patients from the treatment arms (1) valsartan 160 mg od and (2) placebo.
Measure Participants	4645	4661
Number [Percentage of patients]	14.2	15.2

6. Primary Outcome

Title	Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide
Description	The core cardiovascular endpoint was defined as a cardiovascular morbidity/mortality event including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.
Time Frame	Mean patient duration of 5.8 years

Outcome Measure Data

Analysis Population Description

Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies.

Arm/Group Title	Nateglinide	Non-nateglinide
Arm/Group Description	All patients from the treatment arm (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) nateglinide 60 mg ac only.	All patients from the treatment arms (1) valsartan 160 mg od and (2) placebo.
Measure Participants	4645	4661
Number [Percentage of patients]	7.9	8.3

Adverse Events

Time Frame	The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Adverse Event Reporting Description	Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
Arm/Group Title	Valsartan 160 mg od + Nateglinide 60 mg ac		Valsartan 160 mg od + Placebo Nateglinide		Nateglinide 60 mg ac + Placebo Valsartan		Placebo
Arm/Group Description	For the first 2 weeks of treatment, patients took the combination of nateglinide 30 mg (3 times daily ante cibum [ac, before meals]) and valsartan 80 mg (once daily [od] in the morning). After 2 weeks, patients were uptitrated to nateglinide 60 mg ac and valsartan 160 mg od.		For the first 2 weeks of treatment, patients took valsartan 80 mg once daily (od) once in the morning. After 2 weeks, patients were uptitrated to 160 mg valsartan od. Patient also received placebo matching nateglinide tablets identical to the active nateglinide tablets (ac, before meals).		For the first 2 weeks of treatment, patients took one 30 mg tablet of nateglinide with a glass of water 1-30 minutes before each main meal of the day, ie, 3 times daily ante cibum (ac, before meals). If a meal was missed, the patient was not to take a tablet. After 2 weeks, patients were uptitrated to 60 mg nateglinide ac. Patients also received placebo matching valsartan capsules identical to the active valsartan capsules.		Patients took 3 placebo tablets identical to nateglinide tablets 3 times daily ac and 1 placebo capsule identical to valsartan capsule once daily in the morning.
All Cause Mortality
	Valsartan 160 mg od + Nateglinide 60 mg ac		Valsartan 160 mg od + Placebo Nateglinide		Nateglinide 60 mg ac + Placebo Valsartan		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Valsartan 160 mg od + Nateglinide 60 mg ac		Valsartan 160 mg od + Placebo Nateglinide		Nateglinide 60 mg ac + Placebo Valsartan		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1031/2297 (44.9%)		1040/2283 (45.6%)		1035/2305 (44.9%)		1049/2316 (45.3%)
Blood and lymphatic system disorders
Anaemia	19/2297 (0.8%)		10/2283 (0.4%)		18/2305 (0.8%)		19/2316 (0.8%)
Anaemia vitamin B12 deficiency	0/2297 (0%)		3/2283 (0.1%)		0/2305 (0%)		0/2316 (0%)
Bone marrow failure	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Coagulopathy	2/2297 (0.1%)		2/2283 (0.1%)		0/2305 (0%)		0/2316 (0%)
Disseminated intravascular coagulation	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Febrile neutropenia	0/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		0/2316 (0%)
Haemolysis	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Haemorrhagic anaemia	2/2297 (0.1%)		2/2283 (0.1%)		3/2305 (0.1%)		2/2316 (0.1%)
Hilar lymphadenopathy	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Hypochromic anaemia	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Idiopathic thrombocytopenic purpura	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Iron deficiency anaemia	1/2297 (0%)		3/2283 (0.1%)		3/2305 (0.1%)		1/2316 (0%)
Leukocytosis	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		3/2316 (0.1%)
Leukopenia	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Lymphadenopathy	1/2297 (0%)		2/2283 (0.1%)		1/2305 (0%)		0/2316 (0%)
Lymphadenopathy mediastinal	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Neutropenia	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Normochromic normocytic anaemia	0/2297 (0%)		2/2283 (0.1%)		0/2305 (0%)		0/2316 (0%)
Pancytopenia	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Paratracheal lymphadenopathy	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Pernicious anaemia	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Polycythaemia	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Spontaneous haematoma	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Thrombocytopenia	3/2297 (0.1%)		2/2283 (0.1%)		1/2305 (0%)		2/2316 (0.1%)
Thrombocytosis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Cardiac disorders
Accelerated idioventricular rhythm	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Acute coronary syndrome	12/2297 (0.5%)		8/2283 (0.4%)		13/2305 (0.6%)		9/2316 (0.4%)
Acute left ventricular failure	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Acute myocardial infarction	27/2297 (1.2%)		32/2283 (1.4%)		23/2305 (1%)		21/2316 (0.9%)
Angina pectoris	92/2297 (4%)		99/2283 (4.3%)		71/2305 (3.1%)		74/2316 (3.2%)
Angina unstable	46/2297 (2%)		63/2283 (2.8%)		61/2305 (2.6%)		60/2316 (2.6%)
Aortic valve disease	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Aortic valve incompetence	4/2297 (0.2%)		1/2283 (0%)		3/2305 (0.1%)		3/2316 (0.1%)
Aortic valve stenosis	1/2297 (0%)		2/2283 (0.1%)		3/2305 (0.1%)		1/2316 (0%)
Arrhythmia	13/2297 (0.6%)		12/2283 (0.5%)		8/2305 (0.3%)		8/2316 (0.3%)
Arrhythmia supraventricular	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Arteriosclerosis coronary artery	3/2297 (0.1%)		1/2283 (0%)		2/2305 (0.1%)		3/2316 (0.1%)
Arteriospasm coronary	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Atrial fibrillation	60/2297 (2.6%)		46/2283 (2%)		57/2305 (2.5%)		63/2316 (2.7%)
Atrial flutter	8/2297 (0.3%)		3/2283 (0.1%)		7/2305 (0.3%)		5/2316 (0.2%)
Atrioventricular block	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		3/2316 (0.1%)
Atrioventricular block complete	3/2297 (0.1%)		7/2283 (0.3%)		5/2305 (0.2%)		2/2316 (0.1%)
Atrioventricular block first degree	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		3/2316 (0.1%)
Atrioventricular block second degree	2/2297 (0.1%)		2/2283 (0.1%)		5/2305 (0.2%)		1/2316 (0%)
Atrioventricular dissociation	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Bifascicular block	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Bradycardia	9/2297 (0.4%)		10/2283 (0.4%)		11/2305 (0.5%)		9/2316 (0.4%)
Bundle branch block	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Bundle branch block left	3/2297 (0.1%)		1/2283 (0%)		2/2305 (0.1%)		1/2316 (0%)
Bundle branch block right	0/2297 (0%)		3/2283 (0.1%)		1/2305 (0%)		0/2316 (0%)
Cardiac arrest	11/2297 (0.5%)		6/2283 (0.3%)		8/2305 (0.3%)		3/2316 (0.1%)
Cardiac asthma	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Cardiac failure	16/2297 (0.7%)		26/2283 (1.1%)		16/2305 (0.7%)		18/2316 (0.8%)
Cardiac failure acute	1/2297 (0%)		3/2283 (0.1%)		2/2305 (0.1%)		3/2316 (0.1%)
Cardiac failure chronic	2/2297 (0.1%)		4/2283 (0.2%)		3/2305 (0.1%)		3/2316 (0.1%)
Cardiac failure congestive	22/2297 (1%)		32/2283 (1.4%)		37/2305 (1.6%)		35/2316 (1.5%)
Cardiac fibrillation	0/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		0/2316 (0%)
Cardiac hypertrophy	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Cardiac tamponade	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Cardiac valve disease	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Cardio-respiratory arrest	2/2297 (0.1%)		4/2283 (0.2%)		5/2305 (0.2%)		1/2316 (0%)
Cardiogenic shock	2/2297 (0.1%)		2/2283 (0.1%)		5/2305 (0.2%)		2/2316 (0.1%)
Cardiomegaly	1/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		2/2316 (0.1%)
Cardiomyopathy	2/2297 (0.1%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Cardiopulmonary failure	2/2297 (0.1%)		3/2283 (0.1%)		0/2305 (0%)		0/2316 (0%)
Cardiovascular disorder	1/2297 (0%)		2/2283 (0.1%)		0/2305 (0%)		0/2316 (0%)
Cardiovascular insufficiency	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Chronic left ventricular failure	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Conduction disorder	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Congestive cardiomyopathy	3/2297 (0.1%)		1/2283 (0%)		1/2305 (0%)		2/2316 (0.1%)
Cor pulmonale	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Coronary artery disease	43/2297 (1.9%)		37/2283 (1.6%)		50/2305 (2.2%)		42/2316 (1.8%)
Coronary artery dissection	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Coronary artery insufficiency	2/2297 (0.1%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Coronary artery occlusion	8/2297 (0.3%)		10/2283 (0.4%)		6/2305 (0.3%)		9/2316 (0.4%)
Coronary artery perforation	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Coronary artery stenosis	15/2297 (0.7%)		10/2283 (0.4%)		7/2305 (0.3%)		12/2316 (0.5%)
Coronary artery thrombosis	2/2297 (0.1%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Coronary ostial stenosis	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Cyanosis	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Diastolic dysfunction	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Dilatation ventricular	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Electromechanical dissociation	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Extrasystoles	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Hypertensive cardiomyopathy	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Hypertensive heart disease	0/2297 (0%)		2/2283 (0.1%)		1/2305 (0%)		0/2316 (0%)
Hypertrophic cardiomyopathy	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Ischaemic cardiomyopathy	1/2297 (0%)		3/2283 (0.1%)		3/2305 (0.1%)		1/2316 (0%)
Left atrial dilatation	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Left ventricular dysfunction	0/2297 (0%)		3/2283 (0.1%)		4/2305 (0.2%)		0/2316 (0%)
Left ventricular failure	4/2297 (0.2%)		3/2283 (0.1%)		4/2305 (0.2%)		6/2316 (0.3%)
Left ventricular hypertrophy	3/2297 (0.1%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Microvascular angina	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Mitral valve disease	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Mitral valve incompetence	3/2297 (0.1%)		4/2283 (0.2%)		2/2305 (0.1%)		4/2316 (0.2%)
Mitral valve stenosis	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Myocardial fibrosis	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Myocardial infarction	46/2297 (2%)		41/2283 (1.8%)		46/2305 (2%)		46/2316 (2%)
Myocardial ischaemia	20/2297 (0.9%)		17/2283 (0.7%)		22/2305 (1%)		19/2316 (0.8%)
Myocarditis	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Myopericarditis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Nodal arrhythmia	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Nodal rhythm	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Palpitations	6/2297 (0.3%)		3/2283 (0.1%)		4/2305 (0.2%)		7/2316 (0.3%)
Pericardial effusion	4/2297 (0.2%)		2/2283 (0.1%)		1/2305 (0%)		1/2316 (0%)
Pericarditis	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		3/2316 (0.1%)
Postinfarction angina	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Prinzmetal angina	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Reperfusion arrhythmia	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Right ventricular failure	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Sick sinus syndrome	6/2297 (0.3%)		4/2283 (0.2%)		11/2305 (0.5%)		11/2316 (0.5%)
Silent myocardial infarction	2/2297 (0.1%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Sinoatrial block	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Sinus arrest	0/2297 (0%)		2/2283 (0.1%)		0/2305 (0%)		0/2316 (0%)
Sinus arrhythmia	1/2297 (0%)		2/2283 (0.1%)		0/2305 (0%)		1/2316 (0%)
Sinus bradycardia	8/2297 (0.3%)		3/2283 (0.1%)		8/2305 (0.3%)		2/2316 (0.1%)
Sinus tachycardia	1/2297 (0%)		4/2283 (0.2%)		0/2305 (0%)		3/2316 (0.1%)
Subendocardial ischaemia	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Supraventricular extrasystoles	1/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		2/2316 (0.1%)
Supraventricular tachyarrhythmia	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Supraventricular tachycardia	4/2297 (0.2%)		3/2283 (0.1%)		5/2305 (0.2%)		5/2316 (0.2%)
Tachyarrhythmia	0/2297 (0%)		3/2283 (0.1%)		0/2305 (0%)		0/2316 (0%)
Tachycardia	4/2297 (0.2%)		6/2283 (0.3%)		5/2305 (0.2%)		6/2316 (0.3%)
Tricuspid valve incompetence	2/2297 (0.1%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Ventricular arrhythmia	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Ventricular dysfunction	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Ventricular extrasystoles	1/2297 (0%)		6/2283 (0.3%)		5/2305 (0.2%)		3/2316 (0.1%)
Ventricular failure	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Ventricular fibrillation	6/2297 (0.3%)		6/2283 (0.3%)		2/2305 (0.1%)		2/2316 (0.1%)
Ventricular tachyarrhythmia	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Ventricular tachycardia	3/2297 (0.1%)		5/2283 (0.2%)		12/2305 (0.5%)		6/2316 (0.3%)
Wolff-Parkinson-White syndrome	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Congenital, familial and genetic disorders
Atrial septal defect	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Cerebrovascular arteriovenous malformation	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Gastrointestinal angiodysplasia	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Gastrointestinal angiodysplasia haemorrhagic	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Gastrointestinal arteriovenous malformation	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Myocardial bridging	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Vitello-intestinal duct remnant	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Ear and labyrinth disorders
Deafness neurosensory	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Deafness unilateral	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Ear canal stenosis	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Hypoacusis	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Neurosensory hypoacusis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Otosclerosis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Sudden hearing loss	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Tinnitus	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Tympanic membrane perforation	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Vertigo	5/2297 (0.2%)		5/2283 (0.2%)		6/2305 (0.3%)		4/2316 (0.2%)
Vertigo labyrinthine	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Vertigo positional	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		3/2316 (0.1%)
Vestibular disorder	0/2297 (0%)		0/2283 (0%)		3/2305 (0.1%)		1/2316 (0%)
Endocrine disorders
Adrenal cyst	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Adrenal insufficiency	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Adrenal mass	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Autoimmune thyroiditis	2/2297 (0.1%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Goitre	7/2297 (0.3%)		8/2283 (0.4%)		2/2305 (0.1%)		2/2316 (0.1%)
Hyperparathyroidism	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Hyperparathyroidism primary	0/2297 (0%)		2/2283 (0.1%)		0/2305 (0%)		0/2316 (0%)
Hyperthyroidism	5/2297 (0.2%)		4/2283 (0.2%)		2/2305 (0.1%)		1/2316 (0%)
Hypothyroidism	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Inappropriate antidiuretic hormone secretion	2/2297 (0.1%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Parathyroid disorder	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Secondary hyperthyroidism	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Thyroid disorder	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Thyroiditis	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Toxic nodular goitre	2/2297 (0.1%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Eye disorders
Amaurosis fugax	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Blindness	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Blindness transient	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Blindness unilateral	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		2/2316 (0.1%)
Cataract	9/2297 (0.4%)		19/2283 (0.8%)		10/2305 (0.4%)		17/2316 (0.7%)
Cataract nuclear	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Dacryostenosis acquired	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Diabetic retinopathy	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Diplopia	0/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		1/2316 (0%)
Endocrine ophthalmopathy	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Exophthalmos	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Eye haemorrhage	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Eyelid ptosis	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Glaucoma	3/2297 (0.1%)		1/2283 (0%)		3/2305 (0.1%)		0/2316 (0%)
Hyalosis asteroid	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Lens dislocation	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Macular degeneration	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Macular hole	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Maculopathy	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Optic ischaemic neuropathy	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Optic neuropathy	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Panophthalmitis	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Retinal artery occlusion	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Retinal degeneration	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		2/2316 (0.1%)
Retinal detachment	0/2297 (0%)		3/2283 (0.1%)		6/2305 (0.3%)		3/2316 (0.1%)
Retinal haemorrhage	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Retinal ischaemia	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Retinal tear	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Retinal vascular thrombosis	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Retinal vein occlusion	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Retinal vein thrombosis	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Retinopathy	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Retinopathy hypertensive	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Vision blurred	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Visual acuity reduced	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Visual impairment	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Vitreous detachment	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Vitreous haemorrhage	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Gastrointestinal disorders
Abdominal adhesions	1/2297 (0%)		1/2283 (0%)		2/2305 (0.1%)		1/2316 (0%)
Abdominal discomfort	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Abdominal distension	0/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		1/2316 (0%)
Abdominal hernia	4/2297 (0.2%)		5/2283 (0.2%)		4/2305 (0.2%)		4/2316 (0.2%)
Abdominal hernia obstructive	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Abdominal mass	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Abdominal pain	18/2297 (0.8%)		13/2283 (0.6%)		15/2305 (0.7%)		15/2316 (0.6%)
Abdominal pain lower	0/2297 (0%)		4/2283 (0.2%)		1/2305 (0%)		3/2316 (0.1%)
Abdominal pain upper	15/2297 (0.7%)		5/2283 (0.2%)		4/2305 (0.2%)		4/2316 (0.2%)
Abdominal strangulated hernia	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Abdominal tenderness	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Abdominal wall haematoma	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Acute abdomen	2/2297 (0.1%)		2/2283 (0.1%)		0/2305 (0%)		0/2316 (0%)
Alcoholic pancreatitis	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Anal fissure	3/2297 (0.1%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Anal fistula	0/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		1/2316 (0%)
Anal haemorrhage	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Anal polyp	2/2297 (0.1%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Anal prolapse	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Anal skin tags	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Appendix disorder	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Ascites	0/2297 (0%)		5/2283 (0.2%)		1/2305 (0%)		2/2316 (0.1%)
Barrett's oesophagus	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Bezoar	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Colitis	1/2297 (0%)		1/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Colitis ischaemic	2/2297 (0.1%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Colonic fistula	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Colonic polyp	5/2297 (0.2%)		7/2283 (0.3%)		1/2305 (0%)		5/2316 (0.2%)
Constipation	6/2297 (0.3%)		3/2283 (0.1%)		1/2305 (0%)		4/2316 (0.2%)
Crohn's disease	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Diarrhoea	8/2297 (0.3%)		7/2283 (0.3%)		9/2305 (0.4%)		11/2316 (0.5%)
Diarrhoea haemorrhagic	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Diverticular perforation	1/2297 (0%)		2/2283 (0.1%)		1/2305 (0%)		0/2316 (0%)
Diverticulitis intestinal haemorrhagic	1/2297 (0%)		3/2283 (0.1%)		1/2305 (0%)		0/2316 (0%)
Diverticulum	1/2297 (0%)		0/2283 (0%)		6/2305 (0.3%)		2/2316 (0.1%)
Diverticulum intestinal	5/2297 (0.2%)		3/2283 (0.1%)		3/2305 (0.1%)		2/2316 (0.1%)
Diverticulum intestinal haemorrhagic	1/2297 (0%)		2/2283 (0.1%)		2/2305 (0.1%)		2/2316 (0.1%)
Duodenal fistula	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Duodenal perforation	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Duodenal stenosis	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Duodenal ulcer	2/2297 (0.1%)		2/2283 (0.1%)		4/2305 (0.2%)		2/2316 (0.1%)
Duodenal ulcer haemorrhage	2/2297 (0.1%)		1/2283 (0%)		2/2305 (0.1%)		3/2316 (0.1%)
Duodenal ulcer perforation	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Duodenitis	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Dyspepsia	1/2297 (0%)		4/2283 (0.2%)		3/2305 (0.1%)		2/2316 (0.1%)
Dysphagia	3/2297 (0.1%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Enterocele	1/2297 (0%)		1/2283 (0%)		2/2305 (0.1%)		2/2316 (0.1%)
Enterocolonic fistula	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Enterocutaneous fistula	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Erosive oesophagitis	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Faecal incontinence	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Faecaloma	1/2297 (0%)		1/2283 (0%)		1/2305 (0%)		2/2316 (0.1%)
Faeces pale	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Flatulence	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Food poisoning	0/2297 (0%)		3/2283 (0.1%)		0/2305 (0%)		0/2316 (0%)
Gastric haemorrhage	0/2297 (0%)		4/2283 (0.2%)		0/2305 (0%)		5/2316 (0.2%)
Gastric polyps	2/2297 (0.1%)		1/2283 (0%)		1/2305 (0%)		2/2316 (0.1%)
Gastric ulcer	5/2297 (0.2%)		4/2283 (0.2%)		2/2305 (0.1%)		3/2316 (0.1%)
Gastric ulcer haemorrhage	1/2297 (0%)		2/2283 (0.1%)		3/2305 (0.1%)		4/2316 (0.2%)
Gastric volvulus	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Gastritis	8/2297 (0.3%)		6/2283 (0.3%)		8/2305 (0.3%)		6/2316 (0.3%)
Gastritis erosive	4/2297 (0.2%)		1/2283 (0%)		2/2305 (0.1%)		3/2316 (0.1%)
Gastritis haemorrhagic	2/2297 (0.1%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Gastroduodenitis	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Gastrointestinal haemorrhage	9/2297 (0.4%)		9/2283 (0.4%)		12/2305 (0.5%)		11/2316 (0.5%)
Gastrointestinal inflammation	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		2/2316 (0.1%)
Gastrointestinal motility disorder	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Gastrointestinal necrosis	1/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Gastrointestinal obstruction	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Gastrointestinal oedema	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Gastrointestinal pain	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Gastrointestinal telangiectasia	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Gastrointestinal ulcer haemorrhage	1/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		0/2316 (0%)
Gastrolithiasis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Gastrooesophageal reflux disease	4/2297 (0.2%)		6/2283 (0.3%)		4/2305 (0.2%)		2/2316 (0.1%)
Gastrooesophageal sphincter insufficiency	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Gingival bleeding	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Haematemesis	1/2297 (0%)		1/2283 (0%)		2/2305 (0.1%)		2/2316 (0.1%)
Haematochezia	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		2/2316 (0.1%)
Haemorrhagic erosive gastritis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Haemorrhoidal haemorrhage	2/2297 (0.1%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Haemorrhoids	4/2297 (0.2%)		4/2283 (0.2%)		5/2305 (0.2%)		6/2316 (0.3%)
Hernial eventration	0/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		1/2316 (0%)
Hiatus hernia	3/2297 (0.1%)		4/2283 (0.2%)		2/2305 (0.1%)		6/2316 (0.3%)
Hypoaesthesia oral	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Ileal stenosis	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Ileus	5/2297 (0.2%)		2/2283 (0.1%)		1/2305 (0%)		5/2316 (0.2%)
Ileus paralytic	2/2297 (0.1%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Inguinal hernia	18/2297 (0.8%)		22/2283 (1%)		22/2305 (1%)		22/2316 (0.9%)
Inguinal hernia strangulated	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Inguinal hernia, obstructive	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Intestinal fistula	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Intestinal haemorrhage	2/2297 (0.1%)		1/2283 (0%)		2/2305 (0.1%)		1/2316 (0%)
Intestinal ischaemia	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Intestinal obstruction	3/2297 (0.1%)		4/2283 (0.2%)		4/2305 (0.2%)		5/2316 (0.2%)
Intestinal perforation	3/2297 (0.1%)		1/2283 (0%)		2/2305 (0.1%)		2/2316 (0.1%)
Intestinal polyp	0/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		0/2316 (0%)
Intestinal strangulation	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Intra-abdominal haematoma	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Irritable bowel syndrome	1/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		0/2316 (0%)
Ischiorectal hernia	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Large intestinal haemorrhage	0/2297 (0%)		2/2283 (0.1%)		0/2305 (0%)		0/2316 (0%)
Large intestinal stricture	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Large intestine perforation	1/2297 (0%)		2/2283 (0.1%)		0/2305 (0%)		0/2316 (0%)
Leukoplakia oral	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Lower gastrointestinal haemorrhage	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Lumbar hernia	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Mallory-Weiss syndrome	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Mechanical ileus	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Melaena	4/2297 (0.2%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Mesenteric vein thrombosis	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Mouth haemorrhage	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Nausea	7/2297 (0.3%)		10/2283 (0.4%)		9/2305 (0.4%)		9/2316 (0.4%)
Obstruction gastric	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Oesophageal achalasia	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Oesophageal obstruction	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Oesophageal pain	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Oesophageal perforation	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Oesophageal spasm	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Oesophageal ulcer	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Oesophagitis	3/2297 (0.1%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Pancreatic duct obstruction	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		2/2316 (0.1%)
Pancreatic mass	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Pancreatitis	9/2297 (0.4%)		2/2283 (0.1%)		3/2305 (0.1%)		6/2316 (0.3%)
Pancreatitis acute	7/2297 (0.3%)		3/2283 (0.1%)		6/2305 (0.3%)		0/2316 (0%)
Pancreatitis chronic	0/2297 (0%)		2/2283 (0.1%)		0/2305 (0%)		1/2316 (0%)
Pancreatitis haemorrhagic	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Papilla of Vater stenosis	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Peptic ulcer	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		2/2316 (0.1%)
Peptic ulcer haemorrhage	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Peritoneal adhesions	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Peritoneal haemorrhage	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Peritonitis	5/2297 (0.2%)		4/2283 (0.2%)		3/2305 (0.1%)		3/2316 (0.1%)
Polyp colorectal	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Rectal haemorrhage	4/2297 (0.2%)		5/2283 (0.2%)		6/2305 (0.3%)		8/2316 (0.3%)
Rectal polyp	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		2/2316 (0.1%)
Rectal prolapse	1/2297 (0%)		2/2283 (0.1%)		0/2305 (0%)		1/2316 (0%)
Reflux oesophagitis	3/2297 (0.1%)		1/2283 (0%)		1/2305 (0%)		2/2316 (0.1%)
Retroperitoneal haematoma	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Retroperitoneal haemorrhage	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Sigmoiditis	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Small intestinal obstruction	4/2297 (0.2%)		1/2283 (0%)		3/2305 (0.1%)		1/2316 (0%)
Subileus	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		3/2316 (0.1%)
Swollen tongue	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Umbilical hernia	4/2297 (0.2%)		7/2283 (0.3%)		4/2305 (0.2%)		4/2316 (0.2%)
Umbilical hernia, obstructive	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Upper gastrointestinal haemorrhage	1/2297 (0%)		3/2283 (0.1%)		2/2305 (0.1%)		4/2316 (0.2%)
Vomiting	14/2297 (0.6%)		15/2283 (0.7%)		10/2305 (0.4%)		9/2316 (0.4%)
General disorders
Asthenia	4/2297 (0.2%)		6/2283 (0.3%)		6/2305 (0.3%)		8/2316 (0.3%)
Cardiac death	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Catheter related complication	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Catheter thrombosis	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Chest discomfort	3/2297 (0.1%)		2/2283 (0.1%)		3/2305 (0.1%)		3/2316 (0.1%)
Chest pain	15/2297 (0.7%)		6/2283 (0.3%)		10/2305 (0.4%)		12/2316 (0.5%)
Chills	0/2297 (0%)		2/2283 (0.1%)		1/2305 (0%)		1/2316 (0%)
Chronic fatigue syndrome	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Death	10/2297 (0.4%)		19/2283 (0.8%)		11/2305 (0.5%)		14/2316 (0.6%)
Exercise tolerance decreased	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Facial pain	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Fat necrosis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Fatigue	2/2297 (0.1%)		1/2283 (0%)		2/2305 (0.1%)		1/2316 (0%)
Foreign body reaction	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Gait disturbance	1/2297 (0%)		1/2283 (0%)		4/2305 (0.2%)		0/2316 (0%)
General physical health deterioration	3/2297 (0.1%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Generalised oedema	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Hernia	0/2297 (0%)		2/2283 (0.1%)		1/2305 (0%)		0/2316 (0%)
Hernia obstructive	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Hyperplasia	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Hyperpyrexia	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Hypothermia	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Impaired healing	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Implant site haemorrhage	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Inflammation	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Injection site haematoma	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Local swelling	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Malaise	2/2297 (0.1%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Multi-organ failure	3/2297 (0.1%)		4/2283 (0.2%)		2/2305 (0.1%)		6/2316 (0.3%)
Non-cardiac chest pain	45/2297 (2%)		33/2283 (1.4%)		33/2305 (1.4%)		46/2316 (2%)
Oedema	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Oedema peripheral	4/2297 (0.2%)		3/2283 (0.1%)		7/2305 (0.3%)		3/2316 (0.1%)
Pain	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Pelvic mass	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Polyp	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Pyrexia	7/2297 (0.3%)		9/2283 (0.4%)		4/2305 (0.2%)		9/2316 (0.4%)
Submandibular mass	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Sudden cardiac death	7/2297 (0.3%)		6/2283 (0.3%)		11/2305 (0.5%)		12/2316 (0.5%)
Sudden death	2/2297 (0.1%)		1/2283 (0%)		1/2305 (0%)		2/2316 (0.1%)
Systemic inflammatory response syndrome	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Vestibulitis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Hepatobiliary disorders
Alcoholic liver disease	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Bile duct obstruction	1/2297 (0%)		1/2283 (0%)		1/2305 (0%)		2/2316 (0.1%)
Bile duct stenosis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		3/2316 (0.1%)
Bile duct stone	3/2297 (0.1%)		4/2283 (0.2%)		6/2305 (0.3%)		9/2316 (0.4%)
Biliary colic	1/2297 (0%)		0/2283 (0%)		8/2305 (0.3%)		1/2316 (0%)
Biliary dyskinesia	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Biliary fistula	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Biloma	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Cholangitis	3/2297 (0.1%)		3/2283 (0.1%)		3/2305 (0.1%)		3/2316 (0.1%)
Cholangitis acute	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		2/2316 (0.1%)
Cholecystitis	9/2297 (0.4%)		11/2283 (0.5%)		12/2305 (0.5%)		15/2316 (0.6%)
Cholecystitis acute	10/2297 (0.4%)		8/2283 (0.4%)		6/2305 (0.3%)		8/2316 (0.3%)
Cholecystitis chronic	10/2297 (0.4%)		5/2283 (0.2%)		0/2305 (0%)		2/2316 (0.1%)
Cholecystocholangitis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Cholelithiasis	26/2297 (1.1%)		28/2283 (1.2%)		48/2305 (2.1%)		30/2316 (1.3%)
Cholelithiasis obstructive	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Cholestasis	0/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		0/2316 (0%)
Cirrhosis alcoholic	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Cryptogenic cirrhosis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Gallbladder cholesterolosis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Gallbladder disorder	0/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		0/2316 (0%)
Gallbladder fistula	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Gallbladder obstruction	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Gallbladder pain	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Gallbladder perforation	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Hepatic cirrhosis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Hepatic cyst	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Hepatic failure	0/2297 (0%)		1/2283 (0%)		3/2305 (0.1%)		0/2316 (0%)
Hepatic function abnormal	2/2297 (0.1%)		2/2283 (0.1%)		1/2305 (0%)		1/2316 (0%)
Hepatic infarction	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Hepatic lesion	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Hepatic mass	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Hepatic steatosis	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Hepatitis	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Hepatitis alcoholic	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Hepatitis cholestatic	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Hepatitis toxic	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Hepatocellular injury	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Hepatosplenomegaly	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Hydrocholecystis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Hyperbilirubinaemia	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Jaundice	3/2297 (0.1%)		2/2283 (0.1%)		3/2305 (0.1%)		5/2316 (0.2%)
Jaundice cholestatic	4/2297 (0.2%)		1/2283 (0%)		4/2305 (0.2%)		1/2316 (0%)
Jaundice hepatocellular	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Perforation bile duct	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Porcelain gallbladder	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Portal vein thrombosis	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Post cholecystectomy syndrome	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Immune system disorders
Allergy to chemicals	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Anaphylactic reaction	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Anaphylactic shock	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Drug hypersensitivity	3/2297 (0.1%)		1/2283 (0%)		3/2305 (0.1%)		3/2316 (0.1%)
Hypersensitivity	0/2297 (0%)		1/2283 (0%)		2/2305 (0.1%)		0/2316 (0%)
Iodine allergy	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Infections and infestations
Abdominal abscess	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Abdominal infection	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Abscess	3/2297 (0.1%)		2/2283 (0.1%)		1/2305 (0%)		2/2316 (0.1%)
Abscess intestinal	0/2297 (0%)		1/2283 (0%)		2/2305 (0.1%)		1/2316 (0%)
Abscess limb	2/2297 (0.1%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Acute sinusitis	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Acute tonsillitis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		2/2316 (0.1%)
Anal abscess	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Appendiceal abscess	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Appendicitis	4/2297 (0.2%)		2/2283 (0.1%)		5/2305 (0.2%)		9/2316 (0.4%)
Appendicitis perforated	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Arteriovenous graft site infection	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Arthritis bacterial	1/2297 (0%)		3/2283 (0.1%)		0/2305 (0%)		0/2316 (0%)
Arthritis infective	2/2297 (0.1%)		2/2283 (0.1%)		2/2305 (0.1%)		1/2316 (0%)
Bacillus infection	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Bacteraemia	1/2297 (0%)		1/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Bacterial sepsis	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Biliary sepsis	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Biliary tract infection	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Biliary tract infection bacterial	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Borrelia infection	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Breast abscess	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Bronchiectasis	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		2/2316 (0.1%)
Bronchitis	5/2297 (0.2%)		12/2283 (0.5%)		8/2305 (0.3%)		12/2316 (0.5%)
Bronchitis bacterial	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Bronchopneumonia	5/2297 (0.2%)		6/2283 (0.3%)		8/2305 (0.3%)		3/2316 (0.1%)
Bursitis infective	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Campylobacter gastroenteritis	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Campylobacter intestinal infection	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Candidiasis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Carbuncle	2/2297 (0.1%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Catheter related infection	1/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		1/2316 (0%)
Catheter sepsis	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Cellulitis	14/2297 (0.6%)		19/2283 (0.8%)		10/2305 (0.4%)		13/2316 (0.6%)
Cellulitis staphylococcal	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Cellulitis streptococcal	2/2297 (0.1%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Cervicitis	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Chest wall abscess	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Cholecystitis infective	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Chronic sinusitis	3/2297 (0.1%)		1/2283 (0%)		3/2305 (0.1%)		1/2316 (0%)
Citrobacter infection	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Clostridial infection	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Clostridium difficile colitis	3/2297 (0.1%)		0/2283 (0%)		2/2305 (0.1%)		1/2316 (0%)
Clostridium difficile sepsis	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Cystitis	1/2297 (0%)		2/2283 (0.1%)		0/2305 (0%)		2/2316 (0.1%)
Cystitis escherichia	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Dengue fever	2/2297 (0.1%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Device related infection	2/2297 (0.1%)		0/2283 (0%)		1/2305 (0%)		2/2316 (0.1%)
Diarrhoea infectious	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Diverticulitis	5/2297 (0.2%)		7/2283 (0.3%)		7/2305 (0.3%)		12/2316 (0.5%)
Douglas' abscess	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Ear infection	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Ear lobe infection	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Empyema	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Encephalitis viral	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Endocarditis	1/2297 (0%)		5/2283 (0.2%)		1/2305 (0%)		0/2316 (0%)
Endocarditis bacterial	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Endocarditis staphylococcal	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Endometritis	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Epidemic nephropathy	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Epididymal infection	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Erysipelas	6/2297 (0.3%)		6/2283 (0.3%)		3/2305 (0.1%)		5/2316 (0.2%)
Escherichia bacteraemia	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Escherichia infection	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Escherichia sepsis	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Escherichia urinary tract infection	1/2297 (0%)		2/2283 (0.1%)		1/2305 (0%)		4/2316 (0.2%)
Extradural abscess	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Gallbladder empyema	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Gangrene	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Gastric ulcer helicobacter	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Gastroenteritis	10/2297 (0.4%)		12/2283 (0.5%)		6/2305 (0.3%)		7/2316 (0.3%)
Gastroenteritis salmonella	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Gastroenteritis staphylococcal	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Gastroenteritis viral	1/2297 (0%)		4/2283 (0.2%)		4/2305 (0.2%)		4/2316 (0.2%)
Graft infection	0/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		0/2316 (0%)
Groin abscess	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
HIV infection	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Helicobacter gastritis	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Hepatitis non-A non-B	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Hepatitis viral	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Herpes zoster	1/2297 (0%)		3/2283 (0.1%)		1/2305 (0%)		2/2316 (0.1%)
Herpes zoster infection neurological	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Implant site infection	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Incision site infection	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Infected bites	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Infected sebaceous cyst	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Infected skin ulcer	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Infection	3/2297 (0.1%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Infective exacerbation of chronic obstructive airways disease	3/2297 (0.1%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Infective tenosynovitis	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Influenza	1/2297 (0%)		1/2283 (0%)		1/2305 (0%)		2/2316 (0.1%)
Injection site cellulitis	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Kidney infection	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Klebsiella infection	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Labyrinthitis	3/2297 (0.1%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Laryngitis	1/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Liver abscess	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		2/2316 (0.1%)
Lobar pneumonia	3/2297 (0.1%)		3/2283 (0.1%)		2/2305 (0.1%)		1/2316 (0%)
Localised infection	0/2297 (0%)		1/2283 (0%)		2/2305 (0.1%)		1/2316 (0%)
Lower respiratory tract infection	5/2297 (0.2%)		5/2283 (0.2%)		9/2305 (0.4%)		10/2316 (0.4%)
Lower respiratory tract infection fungal	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Lung abscess	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Lung infection	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Lung infection pseudomonal	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Lyme disease	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Lymphangitis	2/2297 (0.1%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Malaria	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Mastoiditis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Mediastinitis	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Meningitis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		2/2316 (0.1%)
Meningitis pneumococcal	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Meningitis viral	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Miliary pneumonia	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Morganella infection	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Nasal abscess	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Nasopharyngitis	1/2297 (0%)		1/2283 (0%)		1/2305 (0%)		2/2316 (0.1%)
Necrotising fasciitis	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Neisseria infection	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Neuroborreliosis	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Neutropenic sepsis	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Orchitis	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Osteomyelitis	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Otitis media	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Paronychia	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Pelvic abscess	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Peridiverticular abscess	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Perihepatic abscess	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Peritoneal abscess	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Peritoneal infection	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Pharyngitis	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Pilonidal cyst	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Pleural infection bacterial	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Pneumonia	47/2297 (2%)		33/2283 (1.4%)		41/2305 (1.8%)		43/2316 (1.9%)
Pneumonia bacterial	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Pneumonia klebsiella	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Pneumonia necrotising	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Pneumonia pneumococcal	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Pneumonia staphylococcal	2/2297 (0.1%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Pneumonia streptococcal	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Pneumonia viral	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Post procedural cellulitis	0/2297 (0%)		0/2283 (0%)		3/2305 (0.1%)		0/2316 (0%)
Post procedural infection	1/2297 (0%)		1/2283 (0%)		5/2305 (0.2%)		1/2316 (0%)
Post procedural pneumonia	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Post procedural sepsis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Postoperative abscess	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Postoperative wound infection	5/2297 (0.2%)		2/2283 (0.1%)		9/2305 (0.4%)		4/2316 (0.2%)
Proteus infection	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Pseudomonas infection	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Pulmonary tuberculosis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Pyelonephritis	0/2297 (0%)		3/2283 (0.1%)		2/2305 (0.1%)		2/2316 (0.1%)
Pyelonephritis acute	1/2297 (0%)		3/2283 (0.1%)		1/2305 (0%)		2/2316 (0.1%)
Pyelonephritis chronic	2/2297 (0.1%)		2/2283 (0.1%)		0/2305 (0%)		1/2316 (0%)
Pyothorax	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		2/2316 (0.1%)
Respiratory tract infection	2/2297 (0.1%)		3/2283 (0.1%)		3/2305 (0.1%)		2/2316 (0.1%)
Respiratory tract infection bacterial	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Respiratory tract infection viral	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Retroperitoneal abscess	0/2297 (0%)		2/2283 (0.1%)		0/2305 (0%)		0/2316 (0%)
Rhinitis	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Salmonellosis	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Salpingitis	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Scrotal abscess	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Scrub typhus	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Sepsis	9/2297 (0.4%)		4/2283 (0.2%)		9/2305 (0.4%)		16/2316 (0.7%)
Septic embolus	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Septic shock	5/2297 (0.2%)		3/2283 (0.1%)		2/2305 (0.1%)		0/2316 (0%)
Shunt infection	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Sialoadenitis	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Sinusitis	1/2297 (0%)		2/2283 (0.1%)		2/2305 (0.1%)		2/2316 (0.1%)
Skin infection	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Staphylococcal infection	1/2297 (0%)		1/2283 (0%)		4/2305 (0.2%)		1/2316 (0%)
Staphylococcal osteomyelitis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Staphylococcal sepsis	1/2297 (0%)		1/2283 (0%)		2/2305 (0.1%)		1/2316 (0%)
Streptococcal infection	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Streptococcal sepsis	2/2297 (0.1%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Subacute endocarditis	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Subcutaneous abscess	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Superinfection	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Tonsillitis streptococcal	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Tracheitis	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Tracheobronchitis	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Tularaemia	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Upper respiratory tract infection	1/2297 (0%)		3/2283 (0.1%)		3/2305 (0.1%)		1/2316 (0%)
Upper respiratory tract infection bacterial	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Urinary tract infection	16/2297 (0.7%)		14/2283 (0.6%)		17/2305 (0.7%)		14/2316 (0.6%)
Urinary tract infection staphylococcal	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Urosepsis	8/2297 (0.3%)		2/2283 (0.1%)		2/2305 (0.1%)		2/2316 (0.1%)
Vaginal infection	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Vaginitis bacterial	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Vestibular neuronitis	1/2297 (0%)		2/2283 (0.1%)		0/2305 (0%)		0/2316 (0%)
Viral infection	2/2297 (0.1%)		1/2283 (0%)		3/2305 (0.1%)		0/2316 (0%)
Viral pericarditis	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Wound abscess	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Wound infection	2/2297 (0.1%)		1/2283 (0%)		3/2305 (0.1%)		1/2316 (0%)
Wound infection bacterial	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Wound infection staphylococcal	1/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		1/2316 (0%)
Wound sepsis	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Injury, poisoning and procedural complications
Abdominal injury	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Abdominal wound dehiscence	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Accident	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Accidental overdose	1/2297 (0%)		2/2283 (0.1%)		0/2305 (0%)		1/2316 (0%)
Acetabulum fracture	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Airway complication of anaesthesia	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Alcohol poisoning	3/2297 (0.1%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Anaemia postoperative	0/2297 (0%)		1/2283 (0%)		2/2305 (0.1%)		0/2316 (0%)
Anaesthetic complication neurological	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Anal injury	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Anastomotic stenosis	0/2297 (0%)		2/2283 (0.1%)		0/2305 (0%)		0/2316 (0%)
Animal bite	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Ankle fracture	5/2297 (0.2%)		5/2283 (0.2%)		5/2305 (0.2%)		6/2316 (0.3%)
Anxiety postoperative	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Arterial injury	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Arteriovenous fistula occlusion	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Arteriovenous graft aneurysm	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Arteriovenous graft thrombosis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Arthropod bite	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Asbestosis	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Back injury	0/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		0/2316 (0%)
Bite	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Bone fissure	1/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		0/2316 (0%)
Brain contusion	1/2297 (0%)		2/2283 (0.1%)		2/2305 (0.1%)		0/2316 (0%)
Burns second degree	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Cardiac function disturbance postoperative	2/2297 (0.1%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Cardiac pacemaker malfunction	0/2297 (0%)		3/2283 (0.1%)		2/2305 (0.1%)		2/2316 (0.1%)
Cardiac procedure complication	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Cartilage injury	2/2297 (0.1%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Cataract operation complication	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Cataract traumatic	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Cervical vertebral fracture	2/2297 (0.1%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Chest injury	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Clavicle fracture	1/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		1/2316 (0%)
Cold exposure injury	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Collapse of lung	1/2297 (0%)		2/2283 (0.1%)		0/2305 (0%)		1/2316 (0%)
Compression fracture	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Concussion	2/2297 (0.1%)		2/2283 (0.1%)		5/2305 (0.2%)		0/2316 (0%)
Contrast media reaction	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Contusion	5/2297 (0.2%)		5/2283 (0.2%)		2/2305 (0.1%)		3/2316 (0.1%)
Corneal scar	2/2297 (0.1%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Coronary artery restenosis	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Cystitis radiation	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Device breakage	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Device dislocation	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Device failure	0/2297 (0%)		0/2283 (0%)		3/2305 (0.1%)		0/2316 (0%)
Device malfunction	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Dislocation of joint prosthesis	0/2297 (0%)		2/2283 (0.1%)		3/2305 (0.1%)		0/2316 (0%)
Dislocation of vertebra	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Drug dose omission	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Drug toxicity	2/2297 (0.1%)		2/2283 (0.1%)		2/2305 (0.1%)		0/2316 (0%)
Electric shock	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Excoriation	3/2297 (0.1%)		4/2283 (0.2%)		0/2305 (0%)		2/2316 (0.1%)
Extradural haematoma	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Eye injury	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Facial bones fracture	0/2297 (0%)		3/2283 (0.1%)		1/2305 (0%)		1/2316 (0%)
Failure of implant	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Fall	46/2297 (2%)		47/2283 (2.1%)		59/2305 (2.6%)		36/2316 (1.6%)
Fat embolism	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Feeding tube complication	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Femoral neck fracture	2/2297 (0.1%)		3/2283 (0.1%)		3/2305 (0.1%)		1/2316 (0%)
Femur fracture	0/2297 (0%)		3/2283 (0.1%)		5/2305 (0.2%)		5/2316 (0.2%)
Fibula fracture	2/2297 (0.1%)		2/2283 (0.1%)		4/2305 (0.2%)		1/2316 (0%)
Foot fracture	0/2297 (0%)		3/2283 (0.1%)		3/2305 (0.1%)		1/2316 (0%)
Forearm fracture	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Foreign body in eye	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Foreign body trauma	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Fractured coccyx	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Gallbladder injury	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Gastrointestinal stoma complication	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Graft thrombosis	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Gun shot wound	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Hand fracture	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Head injury	2/2297 (0.1%)		4/2283 (0.2%)		6/2305 (0.3%)		8/2316 (0.3%)
Hip fracture	5/2297 (0.2%)		5/2283 (0.2%)		5/2305 (0.2%)		5/2316 (0.2%)
Humerus fracture	6/2297 (0.3%)		2/2283 (0.1%)		0/2305 (0%)		0/2316 (0%)
Ilium fracture	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
In-stent arterial restenosis	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
In-stent coronary artery restenosis	3/2297 (0.1%)		3/2283 (0.1%)		2/2305 (0.1%)		1/2316 (0%)
Incisional hernia	7/2297 (0.3%)		8/2283 (0.4%)		3/2305 (0.1%)		4/2316 (0.2%)
Incisional hernia, obstructive	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Injury	2/2297 (0.1%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Intentional overdose	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Intraocular lens dislocation	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Joint dislocation	2/2297 (0.1%)		5/2283 (0.2%)		2/2305 (0.1%)		4/2316 (0.2%)
Joint injury	2/2297 (0.1%)		3/2283 (0.1%)		3/2305 (0.1%)		1/2316 (0%)
Joint sprain	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Laceration	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Ligament injury	3/2297 (0.1%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Ligament rupture	1/2297 (0%)		2/2283 (0.1%)		0/2305 (0%)		5/2316 (0.2%)
Ligament sprain	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Limb crushing injury	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Limb injury	1/2297 (0%)		3/2283 (0.1%)		3/2305 (0.1%)		0/2316 (0%)
Limb traumatic amputation	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Lower limb fracture	2/2297 (0.1%)		1/2283 (0%)		4/2305 (0.2%)		2/2316 (0.1%)
Lumbar vertebral fracture	2/2297 (0.1%)		1/2283 (0%)		3/2305 (0.1%)		0/2316 (0%)
Medication error	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Meniscus lesion	8/2297 (0.3%)		5/2283 (0.2%)		2/2305 (0.1%)		11/2316 (0.5%)
Mental status changes postoperative	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Multiple drug overdose intentional	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Multiple fractures	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Multiple injuries	2/2297 (0.1%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Muscle injury	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Muscle rupture	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Muscle strain	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Nerve injury	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Operative haemorrhage	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Overdose	3/2297 (0.1%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Pacemaker complication	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Patella fracture	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Pelvic fracture	3/2297 (0.1%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Periorbital haematoma	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Poisoning	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Post laminectomy syndrome	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Post procedural complication	6/2297 (0.3%)		2/2283 (0.1%)		2/2305 (0.1%)		5/2316 (0.2%)
Post procedural discharge	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Post procedural discomfort	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Post procedural haematoma	1/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		5/2316 (0.2%)
Post procedural haemorrhage	7/2297 (0.3%)		1/2283 (0%)		0/2305 (0%)		5/2316 (0.2%)
Post procedural pulmonary embolism	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Post-traumatic pain	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Postoperative adhesion	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Postoperative fever	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Postoperative hernia	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Postoperative ileus	2/2297 (0.1%)		2/2283 (0.1%)		0/2305 (0%)		0/2316 (0%)
Postoperative respiratory distress	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Postoperative wound complication	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Procedural complication	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Procedural nausea	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Procedural pain	2/2297 (0.1%)		3/2283 (0.1%)		3/2305 (0.1%)		1/2316 (0%)
Pubic rami fracture	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Radial nerve injury	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Radius fracture	0/2297 (0%)		0/2283 (0%)		4/2305 (0.2%)		3/2316 (0.1%)
Renal injury	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Rib fracture	5/2297 (0.2%)		4/2283 (0.2%)		3/2305 (0.1%)		3/2316 (0.1%)
Road traffic accident	14/2297 (0.6%)		7/2283 (0.3%)		9/2305 (0.4%)		9/2316 (0.4%)
Seroma	3/2297 (0.1%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Shunt occlusion	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Skeletal injury	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Skin laceration	3/2297 (0.1%)		0/2283 (0%)		2/2305 (0.1%)		1/2316 (0%)
Skull fracture	0/2297 (0%)		1/2283 (0%)		3/2305 (0.1%)		1/2316 (0%)
Snake bite	2/2297 (0.1%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Soft tissue injury	2/2297 (0.1%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Spinal compression fracture	2/2297 (0.1%)		1/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Spinal fracture	2/2297 (0.1%)		2/2283 (0.1%)		2/2305 (0.1%)		1/2316 (0%)
Splenic injury	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Splenic rupture	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Stent occlusion	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Sternal fracture	2/2297 (0.1%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Subcutaneous haematoma	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Subdural haematoma	4/2297 (0.2%)		1/2283 (0%)		2/2305 (0.1%)		5/2316 (0.2%)
Subdural haemorrhage	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Synovial rupture	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Tendon injury	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Tendon rupture	5/2297 (0.2%)		2/2283 (0.1%)		3/2305 (0.1%)		2/2316 (0.1%)
Therapeutic agent toxicity	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Thermal burn	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Thrombosis in device	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Tibia fracture	5/2297 (0.2%)		1/2283 (0%)		7/2305 (0.3%)		1/2316 (0%)
Traumatic brain injury	2/2297 (0.1%)		1/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Traumatic haematoma	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Traumatic haemorrhage	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Traumatic shock	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Ulna fracture	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Upper limb fracture	4/2297 (0.2%)		4/2283 (0.2%)		3/2305 (0.1%)		5/2316 (0.2%)
Urinary bladder rupture	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Urostomy complication	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Vascular bypass dysfunction	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Vascular graft occlusion	0/2297 (0%)		4/2283 (0.2%)		4/2305 (0.2%)		3/2316 (0.1%)
Vascular procedure complication	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Vascular pseudoaneurysm	1/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Vertebral injury	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Wound	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Wound complication	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Wound dehiscence	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Wound evisceration	0/2297 (0%)		3/2283 (0.1%)		1/2305 (0%)		1/2316 (0%)
Wound haemorrhage	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Wound secretion	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Wrist fracture	5/2297 (0.2%)		3/2283 (0.1%)		4/2305 (0.2%)		0/2316 (0%)
Investigations
Alanine aminotransferase increased	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Antinuclear antibody increased	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Blood alkaline phosphatase increased	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Blood amylase increased	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Blood potassium decreased	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Blood potassium increased	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Blood sodium decreased	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Body temperature increased	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
C-reactive protein increased	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Chest X-ray abnormal	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Heart rate decreased	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Heart rate irregular	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
International normalised ratio increased	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Liver function test abnormal	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Platelet count decreased	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Prostatic specific antigen increased	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Red blood cell sedimentation rate increased	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Vascular resistance systemic	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Weight decreased	1/2297 (0%)		1/2283 (0%)		4/2305 (0.2%)		0/2316 (0%)
Metabolism and nutrition disorders
Cachexia	0/2297 (0%)		1/2283 (0%)		2/2305 (0.1%)		0/2316 (0%)
Central obesity	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Decreased appetite	3/2297 (0.1%)		1/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Dehydration	12/2297 (0.5%)		10/2283 (0.4%)		12/2305 (0.5%)		15/2316 (0.6%)
Dyslipidaemia	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Electrolyte imbalance	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Failure to thrive	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Fluid overload	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Gout	0/2297 (0%)		3/2283 (0.1%)		1/2305 (0%)		4/2316 (0.2%)
Hypercalcaemia	2/2297 (0.1%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Hypercholesterolaemia	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Hyperglycaemia	1/2297 (0%)		1/2283 (0%)		3/2305 (0.1%)		1/2316 (0%)
Hyperglycaemic hyperosmolar nonketotic syndrome	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Hyperkalaemia	4/2297 (0.2%)		2/2283 (0.1%)		0/2305 (0%)		2/2316 (0.1%)
Hyperlipidaemia	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Hypernatraemia	0/2297 (0%)		2/2283 (0.1%)		0/2305 (0%)		0/2316 (0%)
Hyperosmolar state	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Hyperuricaemia	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Hypoalbuminaemia	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Hypoglycaemia	1/2297 (0%)		3/2283 (0.1%)		1/2305 (0%)		1/2316 (0%)
Hypoglycaemic seizure	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Hypokalaemia	0/2297 (0%)		3/2283 (0.1%)		6/2305 (0.3%)		5/2316 (0.2%)
Hyponatraemia	6/2297 (0.3%)		4/2283 (0.2%)		2/2305 (0.1%)		3/2316 (0.1%)
Hypophosphataemia	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Hypovolaemia	1/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Iron deficiency	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Lactic acidosis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Lipomatosis	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Malnutrition	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Obesity	3/2297 (0.1%)		3/2283 (0.1%)		1/2305 (0%)		0/2316 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	9/2297 (0.4%)		12/2283 (0.5%)		8/2305 (0.3%)		13/2316 (0.6%)
Arthritis	6/2297 (0.3%)		9/2283 (0.4%)		10/2305 (0.4%)		7/2316 (0.3%)
Arthrofibrosis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Arthropathy	0/2297 (0%)		1/2283 (0%)		2/2305 (0.1%)		2/2316 (0.1%)
Back pain	12/2297 (0.5%)		14/2283 (0.6%)		11/2305 (0.5%)		5/2316 (0.2%)
Bone cyst	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Bone erosion	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Bone pain	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Bunion	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Bursa disorder	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Bursitis	3/2297 (0.1%)		2/2283 (0.1%)		1/2305 (0%)		1/2316 (0%)
Cervical spinal stenosis	1/2297 (0%)		1/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Chondrocalcinosis pyrophosphate	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Chondropathy	2/2297 (0.1%)		2/2283 (0.1%)		0/2305 (0%)		2/2316 (0.1%)
Costochondritis	2/2297 (0.1%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Crystal arthropathy	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Dupuytren's contracture	0/2297 (0%)		2/2283 (0.1%)		2/2305 (0.1%)		3/2316 (0.1%)
Exostosis	1/2297 (0%)		2/2283 (0.1%)		1/2305 (0%)		1/2316 (0%)
Facet joint syndrome	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Fibromyalgia	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Fistula	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Foot deformity	1/2297 (0%)		4/2283 (0.2%)		5/2305 (0.2%)		4/2316 (0.2%)
Fracture nonunion	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Gouty arthritis	1/2297 (0%)		2/2283 (0.1%)		2/2305 (0.1%)		0/2316 (0%)
Groin pain	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Intervertebral disc compression	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Intervertebral disc degeneration	4/2297 (0.2%)		0/2283 (0%)		0/2305 (0%)		3/2316 (0.1%)
Intervertebral disc disorder	2/2297 (0.1%)		2/2283 (0.1%)		1/2305 (0%)		2/2316 (0.1%)
Intervertebral disc protrusion	13/2297 (0.6%)		12/2283 (0.5%)		12/2305 (0.5%)		11/2316 (0.5%)
Intervertebral disc space narrowing	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Jaw cyst	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Joint ankylosis	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Joint effusion	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		2/2316 (0.1%)
Joint instability	2/2297 (0.1%)		1/2283 (0%)		0/2305 (0%)		2/2316 (0.1%)
Joint range of motion decreased	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Joint stiffness	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Joint swelling	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Limb deformity	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Loose body in joint	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Lower extremity mass	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Lumbar spinal stenosis	11/2297 (0.5%)		7/2283 (0.3%)		4/2305 (0.2%)		6/2316 (0.3%)
Mobility decreased	1/2297 (0%)		1/2283 (0%)		1/2305 (0%)		2/2316 (0.1%)
Monarthritis	0/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		0/2316 (0%)
Muscle haemorrhage	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Muscle necrosis	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Muscle spasms	1/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Muscular weakness	2/2297 (0.1%)		2/2283 (0.1%)		2/2305 (0.1%)		4/2316 (0.2%)
Musculoskeletal chest pain	6/2297 (0.3%)		4/2283 (0.2%)		5/2305 (0.2%)		4/2316 (0.2%)
Musculoskeletal disorder	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Musculoskeletal pain	5/2297 (0.2%)		5/2283 (0.2%)		5/2305 (0.2%)		1/2316 (0%)
Musculoskeletal stiffness	0/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		0/2316 (0%)
Myalgia	0/2297 (0%)		1/2283 (0%)		2/2305 (0.1%)		2/2316 (0.1%)
Myositis	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		2/2316 (0.1%)
Neck pain	2/2297 (0.1%)		0/2283 (0%)		1/2305 (0%)		2/2316 (0.1%)
Neuropathic arthropathy	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Osteoarthritis	77/2297 (3.4%)		92/2283 (4%)		92/2305 (4%)		93/2316 (4%)
Osteochondrosis	2/2297 (0.1%)		3/2283 (0.1%)		1/2305 (0%)		4/2316 (0.2%)
Osteonecrosis	1/2297 (0%)		1/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Osteoporosis	1/2297 (0%)		1/2283 (0%)		2/2305 (0.1%)		2/2316 (0.1%)
Osteoporotic fracture	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Pain in extremity	6/2297 (0.3%)		8/2283 (0.4%)		7/2305 (0.3%)		11/2316 (0.5%)
Pain in jaw	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Patellofemoral pain syndrome	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Pathological fracture	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Periarthritis	1/2297 (0%)		2/2283 (0.1%)		2/2305 (0.1%)		2/2316 (0.1%)
Plica syndrome	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Polyarthritis	2/2297 (0.1%)		2/2283 (0.1%)		1/2305 (0%)		1/2316 (0%)
Pseudarthrosis	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Psoriatic arthropathy	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Rhabdomyolysis	1/2297 (0%)		2/2283 (0.1%)		1/2305 (0%)		2/2316 (0.1%)
Rheumatoid arthritis	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Rheumatoid nodule	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Rotator cuff syndrome	6/2297 (0.3%)		3/2283 (0.1%)		4/2305 (0.2%)		5/2316 (0.2%)
Spinal column stenosis	7/2297 (0.3%)		3/2283 (0.1%)		6/2305 (0.3%)		8/2316 (0.3%)
Spinal disorder	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Spinal fusion acquired	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Spinal osteoarthritis	7/2297 (0.3%)		10/2283 (0.4%)		5/2305 (0.2%)		6/2316 (0.3%)
Spondylitis	0/2297 (0%)		3/2283 (0.1%)		0/2305 (0%)		1/2316 (0%)
Spondylolisthesis	3/2297 (0.1%)		1/2283 (0%)		0/2305 (0%)		4/2316 (0.2%)
Spondylolysis	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Sympathetic posterior cervical syndrome	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Synovial cyst	1/2297 (0%)		3/2283 (0.1%)		0/2305 (0%)		2/2316 (0.1%)
Synovitis	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Tendon disorder	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Tendonitis	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Tenosynovitis	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal neoplasm	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Acoustic neuroma	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Acute leukaemia	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Acute myeloid leukaemia	2/2297 (0.1%)		1/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Adenocarcinoma	2/2297 (0.1%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Adenocarcinoma pancreas	2/2297 (0.1%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Adenosquamous cell lung cancer	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Adenosquamous cell lung cancer stage II	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Adrenal adenoma	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Angiomyolipoma	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
B-cell lymphoma	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Basal cell carcinoma	9/2297 (0.4%)		16/2283 (0.7%)		14/2305 (0.6%)		16/2316 (0.7%)
Basosquamous carcinoma	0/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		0/2316 (0%)
Benign bone neoplasm	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Benign breast neoplasm	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Benign colonic neoplasm	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Benign laryngeal neoplasm	0/2297 (0%)		2/2283 (0.1%)		0/2305 (0%)		1/2316 (0%)
Benign lung neoplasm	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Benign neoplasm of adrenal gland	2/2297 (0.1%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Benign neoplasm of bladder	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		2/2316 (0.1%)
Benign neoplasm of orbit	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Benign neoplasm of prostate	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Benign neoplasm of skin	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Benign neoplasm of thyroid gland	1/2297 (0%)		2/2283 (0.1%)		0/2305 (0%)		1/2316 (0%)
Benign ovarian tumour	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Benign pancreatic neoplasm	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Benign renal neoplasm	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Benign salivary gland neoplasm	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Benign uterine neoplasm	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Bile duct cancer	1/2297 (0%)		2/2283 (0.1%)		0/2305 (0%)		1/2316 (0%)
Biliary neoplasm	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Bladder adenocarcinoma stage unspecified	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Bladder cancer	3/2297 (0.1%)		4/2283 (0.2%)		3/2305 (0.1%)		10/2316 (0.4%)
Bladder cancer recurrent	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Bladder neoplasm	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Bladder papilloma	0/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		0/2316 (0%)
Bladder transitional cell carcinoma	1/2297 (0%)		4/2283 (0.2%)		3/2305 (0.1%)		3/2316 (0.1%)
Bone neoplasm malignant	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Bowen's disease	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Brain neoplasm	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		2/2316 (0.1%)
Breast adenoma	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Breast cancer	20/2297 (0.9%)		24/2283 (1.1%)		20/2305 (0.9%)		14/2316 (0.6%)
Breast cancer female	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Breast cancer in situ	1/2297 (0%)		3/2283 (0.1%)		2/2305 (0.1%)		1/2316 (0%)
Breast cancer metastatic	2/2297 (0.1%)		1/2283 (0%)		1/2305 (0%)		2/2316 (0.1%)
Breast cancer recurrent	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Breast fibroma	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Bronchial carcinoma	0/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		1/2316 (0%)
Bronchial neoplasm	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Bronchioloalveolar carcinoma	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Cancer pain	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Carcinoid tumour of the gastrointestinal tract	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Carcinoma in situ of skin	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Cardiac myxoma	1/2297 (0%)		1/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Cervix carcinoma	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Cholesteatoma	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Chondroma	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Chronic lymphocytic leukaemia	1/2297 (0%)		1/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Chronic lymphocytic leukaemia stage 0	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Colon adenoma	1/2297 (0%)		1/2283 (0%)		2/2305 (0.1%)		1/2316 (0%)
Colon cancer	19/2297 (0.8%)		16/2283 (0.7%)		13/2305 (0.6%)		12/2316 (0.5%)
Colon cancer metastatic	2/2297 (0.1%)		2/2283 (0.1%)		0/2305 (0%)		2/2316 (0.1%)
Colon cancer recurrent	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Colon cancer stage IV	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Colon neoplasm	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Colorectal cancer	1/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Endocrine neoplasm malignant	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Endometrial cancer	3/2297 (0.1%)		2/2283 (0.1%)		2/2305 (0.1%)		4/2316 (0.2%)
Endometrial cancer metastatic	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Essential thrombocythaemia	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Fallopian tube cancer	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Female reproductive neoplasm	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Fibroadenoma of breast	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Gallbladder cancer	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Gastric cancer	1/2297 (0%)		4/2283 (0.2%)		7/2305 (0.3%)		5/2316 (0.2%)
Gastric neoplasm	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Gastrointestinal carcinoma	2/2297 (0.1%)		3/2283 (0.1%)		4/2305 (0.2%)		3/2316 (0.1%)
Gastrointestinal stromal tumour	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Gastrointestinal tract adenoma	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Glioblastoma	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Glioblastoma multiforme	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Glioma	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Gliosarcoma	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Haemangioma	2/2297 (0.1%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Haemangioma of liver	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Haemangiopericytoma	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Head and neck cancer	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Hepatic neoplasm	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Hepatic neoplasm malignant	1/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		0/2316 (0%)
Hodgkin's disease	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Hypergammaglobulinaemia benign monoclonal	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Hypopharyngeal cancer	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Intestinal adenocarcinoma	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Intracranial meningioma malignant	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Large intestine carcinoma	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Laryngeal cancer	2/2297 (0.1%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Lentigo maligna stage unspecified	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Leukaemia	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Lip and/or oral cavity cancer	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Lipoma	3/2297 (0.1%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Lipoma of breast	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Liposarcoma metastatic	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Lung adenocarcinoma	4/2297 (0.2%)		3/2283 (0.1%)		2/2305 (0.1%)		2/2316 (0.1%)
Lung cancer metastatic	0/2297 (0%)		2/2283 (0.1%)		3/2305 (0.1%)		1/2316 (0%)
Lung carcinoma cell type unspecified stage IV	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Lung neoplasm	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Lung neoplasm malignant	8/2297 (0.3%)		9/2283 (0.4%)		16/2305 (0.7%)		16/2316 (0.7%)
Lung squamous cell carcinoma stage unspecified	2/2297 (0.1%)		1/2283 (0%)		2/2305 (0.1%)		1/2316 (0%)
Lymphocytic leukaemia	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Lymphoma	4/2297 (0.2%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Malignant ascites	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Malignant fibrous histiocytoma	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Malignant melanoma	2/2297 (0.1%)		3/2283 (0.1%)		3/2305 (0.1%)		3/2316 (0.1%)
Malignant melanoma in situ	2/2297 (0.1%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Malignant melanoma of eyelid	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Malignant peritoneal neoplasm	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Malignant pleural effusion	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Malignant urinary tract neoplasm	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Melanocytic naevus	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Meningioma	2/2297 (0.1%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Meningioma benign	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Mesothelioma malignant	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Metastases to abdominal cavity	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Metastases to adrenals	5/2297 (0.2%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Metastases to bone	5/2297 (0.2%)		6/2283 (0.3%)		4/2305 (0.2%)		5/2316 (0.2%)
Metastases to central nervous system	5/2297 (0.2%)		3/2283 (0.1%)		2/2305 (0.1%)		2/2316 (0.1%)
Metastases to chest wall	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Metastases to gastrointestinal tract	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Metastases to kidney	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Metastases to large intestine	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Metastases to liver	11/2297 (0.5%)		7/2283 (0.3%)		13/2305 (0.6%)		10/2316 (0.4%)
Metastases to lung	10/2297 (0.4%)		6/2283 (0.3%)		4/2305 (0.2%)		7/2316 (0.3%)
Metastases to lymph nodes	4/2297 (0.2%)		2/2283 (0.1%)		1/2305 (0%)		2/2316 (0.1%)
Metastases to meninges	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Metastases to ovary	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Metastases to pancreas	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Metastases to peritoneum	4/2297 (0.2%)		1/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Metastases to pleura	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		2/2316 (0.1%)
Metastases to skin	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Metastases to small intestine	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Metastases to soft tissue	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Metastases to spine	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Metastases to stomach	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Metastases to the mediastinum	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Metastasis	0/2297 (0%)		0/2283 (0%)		4/2305 (0.2%)		0/2316 (0%)
Metastatic carcinoma of the bladder	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Metastatic malignant melanoma	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Metastatic neoplasm	6/2297 (0.3%)		1/2283 (0%)		2/2305 (0.1%)		4/2316 (0.2%)
Metastatic renal cell carcinoma	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Multiple myeloma	2/2297 (0.1%)		4/2283 (0.2%)		2/2305 (0.1%)		2/2316 (0.1%)
Myelodysplastic syndrome	2/2297 (0.1%)		1/2283 (0%)		0/2305 (0%)		3/2316 (0.1%)
Nasal neoplasm benign	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Nasal sinus cancer	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Nasopharyngeal cancer	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Neuroma	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Non-Hodgkin's lymphoma	1/2297 (0%)		1/2283 (0%)		2/2305 (0.1%)		3/2316 (0.1%)
Non-Hodgkin's lymphoma stage IV	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Non-small cell lung cancer	2/2297 (0.1%)		0/2283 (0%)		2/2305 (0.1%)		1/2316 (0%)
Non-small cell lung cancer stage IV	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Oesophageal adenocarcinoma	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Oesophageal cancer metastatic	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Oesophageal carcinoma	2/2297 (0.1%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Ovarian adenoma	1/2297 (0%)		2/2283 (0.1%)		0/2305 (0%)		1/2316 (0%)
Ovarian cancer	3/2297 (0.1%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Ovarian cancer metastatic	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Ovarian epithelial cancer	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Paget's disease of the vulva	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Pancreatic carcinoma	7/2297 (0.3%)		4/2283 (0.2%)		2/2305 (0.1%)		5/2316 (0.2%)
Pancreatic carcinoma metastatic	1/2297 (0%)		4/2283 (0.2%)		0/2305 (0%)		1/2316 (0%)
Pancreatic neoplasm	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Paraneoplastic syndrome	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Parathyroid tumour benign	0/2297 (0%)		3/2283 (0.1%)		0/2305 (0%)		0/2316 (0%)
Pharyngeal cancer metastatic	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Pituitary tumour	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Prostate cancer	37/2297 (1.6%)		36/2283 (1.6%)		34/2305 (1.5%)		30/2316 (1.3%)
Prostate cancer metastatic	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Prostate cancer stage I	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Prostate cancer stage II	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Prostate cancer stage III	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Prostatic adenoma	2/2297 (0.1%)		3/2283 (0.1%)		2/2305 (0.1%)		1/2316 (0%)
Rectal adenoma	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Rectal cancer	3/2297 (0.1%)		6/2283 (0.3%)		5/2305 (0.2%)		5/2316 (0.2%)
Rectal cancer metastatic	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		3/2316 (0.1%)
Rectal cancer stage I	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Rectal cancer stage II	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Rectal neoplasm	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Rectosigmoid cancer	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Renal adenoma	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Renal cancer	5/2297 (0.2%)		2/2283 (0.1%)		3/2305 (0.1%)		1/2316 (0%)
Renal cancer metastatic	0/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		1/2316 (0%)
Renal cell carcinoma	5/2297 (0.2%)		3/2283 (0.1%)		0/2305 (0%)		2/2316 (0.1%)
Renal cell carcinoma stage I	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Renal neoplasm	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Renal oncocytoma	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Retroperitoneal cancer	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Retroperitoneal neoplasm	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Rosai-Dorfman syndrome	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Salivary gland adenoma	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Sarcoma	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Sarcoma uterus	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Seborrhoeic keratosis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Skin cancer	3/2297 (0.1%)		2/2283 (0.1%)		1/2305 (0%)		0/2316 (0%)
Small cell carcinoma	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Small cell lung cancer metastatic	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Small cell lung cancer stage unspecified	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		2/2316 (0.1%)
Small intestine carcinoma metastatic	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Squamous cell carcinoma	2/2297 (0.1%)		3/2283 (0.1%)		3/2305 (0.1%)		1/2316 (0%)
Squamous cell carcinoma of skin	7/2297 (0.3%)		2/2283 (0.1%)		1/2305 (0%)		5/2316 (0.2%)
Testis cancer	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Thyroid adenoma	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Thyroid cancer	2/2297 (0.1%)		0/2283 (0%)		2/2305 (0.1%)		2/2316 (0.1%)
Thyroid cancer metastatic	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Tongue neoplasm malignant stage unspecified	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Tonsil cancer	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Tonsillar neoplasm	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Tonsillar neoplasm benign	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Transitional cell cancer of the renal pelvis and ureter	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Transitional cell carcinoma	2/2297 (0.1%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Tumour necrosis	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Undifferentiated sarcoma	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Ureteric cancer	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Uterine cancer	4/2297 (0.2%)		2/2283 (0.1%)		1/2305 (0%)		3/2316 (0.1%)
Uterine leiomyoma	4/2297 (0.2%)		3/2283 (0.1%)		3/2305 (0.1%)		1/2316 (0%)
Uterine neoplasm	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Vaginal cancer	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Vulval cancer	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Nervous system disorders
Alcoholic seizure	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Altered state of consciousness	0/2297 (0%)		0/2283 (0%)		3/2305 (0.1%)		0/2316 (0%)
Amnesia	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Amnestic disorder	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Amyotrophic lateral sclerosis	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Anoxic encephalopathy	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Aphasia	2/2297 (0.1%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Arachnoid cyst	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Ataxia	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Autonomic nervous system imbalance	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Balance disorder	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		2/2316 (0.1%)
Basilar artery stenosis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Brain oedema	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Carotid arteriosclerosis	0/2297 (0%)		2/2283 (0.1%)		1/2305 (0%)		2/2316 (0.1%)
Carotid artery occlusion	0/2297 (0%)		0/2283 (0%)		4/2305 (0.2%)		0/2316 (0%)
Carotid artery stenosis	12/2297 (0.5%)		12/2283 (0.5%)		16/2305 (0.7%)		14/2316 (0.6%)
Carotid sinus syndrome	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Carpal tunnel syndrome	1/2297 (0%)		1/2283 (0%)		2/2305 (0.1%)		1/2316 (0%)
Cataplexy	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Cerebellar atrophy	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Cerebellar haematoma	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Cerebellar infarction	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Cerebellar syndrome	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Cerebral arteriosclerosis	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Cerebral artery occlusion	1/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		0/2316 (0%)
Cerebral artery stenosis	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		2/2316 (0.1%)
Cerebral atrophy	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Cerebral circulatory failure	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Cerebral cyst	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Cerebral haematoma	0/2297 (0%)		2/2283 (0.1%)		0/2305 (0%)		0/2316 (0%)
Cerebral haemorrhage	2/2297 (0.1%)		1/2283 (0%)		3/2305 (0.1%)		3/2316 (0.1%)
Cerebral infarction	5/2297 (0.2%)		6/2283 (0.3%)		4/2305 (0.2%)		6/2316 (0.3%)
Cerebral ischaemia	1/2297 (0%)		1/2283 (0%)		2/2305 (0.1%)		1/2316 (0%)
Cerebral thrombosis	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Cerebrosclerosis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Cerebrospinal fluid rhinorrhoea	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Cerebrovascular accident	22/2297 (1%)		34/2283 (1.5%)		28/2305 (1.2%)		40/2316 (1.7%)
Cerebrovascular disorder	1/2297 (0%)		1/2283 (0%)		2/2305 (0.1%)		2/2316 (0.1%)
Cerebrovascular insufficiency	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Cerebrovascular stenosis	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Cervical myelopathy	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Cervicobrachial syndrome	1/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Cervicogenic headache	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Cognitive disorder	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Coma	4/2297 (0.2%)		1/2283 (0%)		4/2305 (0.2%)		2/2316 (0.1%)
Complex partial seizures	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Convulsion	3/2297 (0.1%)		4/2283 (0.2%)		5/2305 (0.2%)		5/2316 (0.2%)
Coordination abnormal	0/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		0/2316 (0%)
Dementia	0/2297 (0%)		0/2283 (0%)		5/2305 (0.2%)		2/2316 (0.1%)
Dementia Alzheimer's type	0/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		0/2316 (0%)
Depressed level of consciousness	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Diabetic neuropathy	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Dizziness	12/2297 (0.5%)		10/2283 (0.4%)		13/2305 (0.6%)		11/2316 (0.5%)
Dizziness postural	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Drop attacks	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Dysaesthesia	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Dysarthria	0/2297 (0%)		1/2283 (0%)		2/2305 (0.1%)		2/2316 (0.1%)
Dyskinesia	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Embolic stroke	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Encephalomalacia	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Encephalopathy	0/2297 (0%)		1/2283 (0%)		3/2305 (0.1%)		1/2316 (0%)
Epilepsy	2/2297 (0.1%)		3/2283 (0.1%)		3/2305 (0.1%)		3/2316 (0.1%)
Extrapyramidal disorder	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Facial palsy	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		3/2316 (0.1%)
Facial paresis	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Grand mal convulsion	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Guillain-Barre syndrome	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Haemorrhage intracranial	0/2297 (0%)		2/2283 (0.1%)		2/2305 (0.1%)		1/2316 (0%)
Haemorrhagic stroke	5/2297 (0.2%)		5/2283 (0.2%)		4/2305 (0.2%)		3/2316 (0.1%)
Headache	5/2297 (0.2%)		3/2283 (0.1%)		6/2305 (0.3%)		4/2316 (0.2%)
Hemiparesis	2/2297 (0.1%)		3/2283 (0.1%)		4/2305 (0.2%)		2/2316 (0.1%)
Hemiplegia	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Hepatic encephalopathy	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Horner's syndrome	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Hydrocephalus	2/2297 (0.1%)		3/2283 (0.1%)		2/2305 (0.1%)		2/2316 (0.1%)
Hypertonia	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Hypoaesthesia	3/2297 (0.1%)		0/2283 (0%)		3/2305 (0.1%)		3/2316 (0.1%)
Hyporeflexia	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
IIIrd nerve paralysis	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Intracranial aneurysm	2/2297 (0.1%)		2/2283 (0.1%)		1/2305 (0%)		0/2316 (0%)
Intracranial pressure increased	0/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		0/2316 (0%)
Ischaemic cerebral infarction	2/2297 (0.1%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Ischaemic stroke	16/2297 (0.7%)		10/2283 (0.4%)		13/2305 (0.6%)		14/2316 (0.6%)
Lacunar infarction	1/2297 (0%)		2/2283 (0.1%)		1/2305 (0%)		2/2316 (0.1%)
Lethargy	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		2/2316 (0.1%)
Leukoaraiosis	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Loss of consciousness	10/2297 (0.4%)		9/2283 (0.4%)		6/2305 (0.3%)		8/2316 (0.3%)
Lumbar radiculopathy	0/2297 (0%)		2/2283 (0.1%)		1/2305 (0%)		2/2316 (0.1%)
Memory impairment	2/2297 (0.1%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Mental impairment	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Migraine	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Morton's neuralgia	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Multiple system atrophy	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Myasthenia gravis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Myelopathy	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Nerve compression	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		4/2316 (0.2%)
Nerve root compression	2/2297 (0.1%)		0/2283 (0%)		2/2305 (0.1%)		0/2316 (0%)
Nerve root lesion	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Nervous system disorder	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Neuralgia	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Neuropathy peripheral	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Normal pressure hydrocephalus	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Nystagmus	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Paraesthesia	0/2297 (0%)		3/2283 (0.1%)		1/2305 (0%)		5/2316 (0.2%)
Paralysis	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Paraplegia	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Parkinson's disease	2/2297 (0.1%)		2/2283 (0.1%)		1/2305 (0%)		3/2316 (0.1%)
Parkinsonism	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Partial seizures	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Peroneal nerve palsy	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Petit mal epilepsy	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Polyneuropathy	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		2/2316 (0.1%)
Presyncope	10/2297 (0.4%)		10/2283 (0.4%)		9/2305 (0.4%)		6/2316 (0.3%)
Quadriparesis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Radicular syndrome	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Radiculitis cervical	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Radiculopathy	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Reversible ischaemic neurological deficit	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Ruptured cerebral aneurysm	2/2297 (0.1%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Sciatica	3/2297 (0.1%)		3/2283 (0.1%)		2/2305 (0.1%)		2/2316 (0.1%)
Senile dementia	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Somnolence	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Spinal claudication	3/2297 (0.1%)		1/2283 (0%)		0/2305 (0%)		2/2316 (0.1%)
Spinal cord compression	1/2297 (0%)		1/2283 (0%)		2/2305 (0.1%)		0/2316 (0%)
Spinal cord ischaemia	2/2297 (0.1%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Spinal vascular disorder	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Spondylitic myelopathy	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Status epilepticus	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Stupor	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		2/2316 (0.1%)
Subarachnoid haemorrhage	2/2297 (0.1%)		3/2283 (0.1%)		3/2305 (0.1%)		2/2316 (0.1%)
Syncope	33/2297 (1.4%)		29/2283 (1.3%)		26/2305 (1.1%)		34/2316 (1.5%)
Thalamus haemorrhage	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Thoracic outlet syndrome	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Thrombotic stroke	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Tonic convulsion	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Transient global amnesia	2/2297 (0.1%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Transient ischaemic attack	26/2297 (1.1%)		27/2283 (1.2%)		18/2305 (0.8%)		24/2316 (1%)
Tremor	0/2297 (0%)		0/2283 (0%)		3/2305 (0.1%)		1/2316 (0%)
Trigeminal neuralgia	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Unresponsive to stimuli	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
VIIth nerve paralysis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Vascular dementia	0/2297 (0%)		2/2283 (0.1%)		0/2305 (0%)		1/2316 (0%)
Vascular encephalopathy	1/2297 (0%)		2/2283 (0.1%)		0/2305 (0%)		2/2316 (0.1%)
Vasculitis cerebral	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Vertebral artery stenosis	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Vertebral artery thrombosis	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Vertebrobasilar insufficiency	1/2297 (0%)		2/2283 (0.1%)		1/2305 (0%)		2/2316 (0.1%)
Wallenberg syndrome	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Psychiatric disorders
Acute psychosis	0/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		1/2316 (0%)
Acute stress disorder	0/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		0/2316 (0%)
Adjustment disorder	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Affect lability	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Agitation	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Alcohol abuse	0/2297 (0%)		1/2283 (0%)		2/2305 (0.1%)		0/2316 (0%)
Alcohol withdrawal syndrome	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Alcoholism	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Anxiety	0/2297 (0%)		4/2283 (0.2%)		1/2305 (0%)		4/2316 (0.2%)
Anxiety disorder	2/2297 (0.1%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Bipolar I disorder	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Bipolar disorder	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Completed suicide	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		2/2316 (0.1%)
Confusional state	4/2297 (0.2%)		3/2283 (0.1%)		4/2305 (0.2%)		5/2316 (0.2%)
Delirium	0/2297 (0%)		4/2283 (0.2%)		2/2305 (0.1%)		1/2316 (0%)
Delirium tremens	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Delusion	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Depression	5/2297 (0.2%)		4/2283 (0.2%)		5/2305 (0.2%)		4/2316 (0.2%)
Depression suicidal	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Depressive symptom	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Disorientation	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Emotional distress	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Hallucination	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Hallucination, auditory	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Intentional self-injury	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Major depression	1/2297 (0%)		4/2283 (0.2%)		1/2305 (0%)		1/2316 (0%)
Mental status changes	1/2297 (0%)		2/2283 (0.1%)		2/2305 (0.1%)		2/2316 (0.1%)
Nervousness	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Obsessive thoughts	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Post-traumatic stress disorder	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Psychotic disorder	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Restlessness	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Schizophrenia	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Somatoform disorder	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Stress	2/2297 (0.1%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Suicidal ideation	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Suicide attempt	1/2297 (0%)		2/2283 (0.1%)		1/2305 (0%)		0/2316 (0%)
Renal and urinary disorders
Acute prerenal failure	1/2297 (0%)		2/2283 (0.1%)		0/2305 (0%)		0/2316 (0%)
Anuria	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Azotaemia	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Bladder disorder	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Bladder hypertrophy	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Bladder neck obstruction	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Bladder obstruction	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Bladder perforation	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Bladder prolapse	2/2297 (0.1%)		1/2283 (0%)		1/2305 (0%)		4/2316 (0.2%)
Calculus bladder	0/2297 (0%)		2/2283 (0.1%)		0/2305 (0%)		0/2316 (0%)
Calculus ureteric	4/2297 (0.2%)		1/2283 (0%)		5/2305 (0.2%)		3/2316 (0.1%)
Calculus urinary	3/2297 (0.1%)		1/2283 (0%)		2/2305 (0.1%)		3/2316 (0.1%)
Chromaturia	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Cystitis haemorrhagic	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Cystitis noninfective	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Diabetic nephropathy	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Dysuria	1/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		2/2316 (0.1%)
Glomerulonephritis	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Glomerulonephritis chronic	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Haematuria	8/2297 (0.3%)		7/2283 (0.3%)		6/2305 (0.3%)		3/2316 (0.1%)
Haemorrhage urinary tract	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Hydronephrosis	1/2297 (0%)		4/2283 (0.2%)		5/2305 (0.2%)		2/2316 (0.1%)
Hydroureter	0/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		0/2316 (0%)
Hypertensive nephropathy	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Hypotonic urinary bladder	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Incontinence	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Nephritis	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Nephrolithiasis	13/2297 (0.6%)		9/2283 (0.4%)		11/2305 (0.5%)		12/2316 (0.5%)
Nephrotic syndrome	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Obstructive uropathy	2/2297 (0.1%)		1/2283 (0%)		2/2305 (0.1%)		0/2316 (0%)
Oliguria	0/2297 (0%)		2/2283 (0.1%)		0/2305 (0%)		1/2316 (0%)
Pollakiuria	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		2/2316 (0.1%)
Polyuria	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Proteinuria	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Renal artery stenosis	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		3/2316 (0.1%)
Renal atrophy	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Renal colic	3/2297 (0.1%)		6/2283 (0.3%)		5/2305 (0.2%)		1/2316 (0%)
Renal cyst	4/2297 (0.2%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Renal disorder	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Renal failure	5/2297 (0.2%)		11/2283 (0.5%)		15/2305 (0.7%)		8/2316 (0.3%)
Renal failure acute	14/2297 (0.6%)		10/2283 (0.4%)		11/2305 (0.5%)		6/2316 (0.3%)
Renal failure chronic	5/2297 (0.2%)		3/2283 (0.1%)		1/2305 (0%)		3/2316 (0.1%)
Renal impairment	1/2297 (0%)		1/2283 (0%)		3/2305 (0.1%)		3/2316 (0.1%)
Renal mass	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Renal pelvis fistula	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Renal tubular necrosis	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Stress urinary incontinence	3/2297 (0.1%)		3/2283 (0.1%)		1/2305 (0%)		3/2316 (0.1%)
Ureteric obstruction	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		2/2316 (0.1%)
Ureteric perforation	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Ureteric stenosis	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Urethral caruncle	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Urethral disorder	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Urethral meatus stenosis	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Urethral obstruction	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Urethral stenosis	3/2297 (0.1%)		2/2283 (0.1%)		2/2305 (0.1%)		1/2316 (0%)
Urethral ulcer	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Urinary bladder haemorrhage	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Urinary bladder polyp	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Urinary incontinence	6/2297 (0.3%)		4/2283 (0.2%)		4/2305 (0.2%)		3/2316 (0.1%)
Urinary retention	6/2297 (0.3%)		7/2283 (0.3%)		8/2305 (0.3%)		6/2316 (0.3%)
Urinary tract obstruction	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Vesical fistula	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Vesicoureteric reflux	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Reproductive system and breast disorders
Acquired hydrocele	1/2297 (0%)		3/2283 (0.1%)		4/2305 (0.2%)		2/2316 (0.1%)
Acquired phimosis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Adenomyosis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Atrophic vulvovaginitis	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Benign prostatic hyperplasia	19/2297 (0.8%)		17/2283 (0.7%)		28/2305 (1.2%)		27/2316 (1.2%)
Breast calcifications	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Breast cyst	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Breast disorder	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Breast hyperplasia	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Breast mass	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Cervical dysplasia	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Cervical polyp	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Cervix inflammation	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Colpocele	0/2297 (0%)		2/2283 (0.1%)		1/2305 (0%)		0/2316 (0%)
Cystocele	7/2297 (0.3%)		8/2283 (0.4%)		1/2305 (0%)		5/2316 (0.2%)
Endometrial atrophy	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Endometrial hyperplasia	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		2/2316 (0.1%)
Epididymal cyst	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Epididymitis	2/2297 (0.1%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Erectile dysfunction	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Female genital tract fistula	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Fibrocystic breast disease	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Genital prolapse	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		2/2316 (0.1%)
Gynaecomastia	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Mammary duct ectasia	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Menorrhagia	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Metrorrhagia	2/2297 (0.1%)		1/2283 (0%)		2/2305 (0.1%)		0/2316 (0%)
Nipple exudate bloody	0/2297 (0%)		2/2283 (0.1%)		0/2305 (0%)		0/2316 (0%)
Ovarian atrophy	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Ovarian cyst	5/2297 (0.2%)		6/2283 (0.3%)		3/2305 (0.1%)		4/2316 (0.2%)
Pelvic adhesions	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Pelvic pain	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Perineal pain	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Postmenopausal haemorrhage	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Prostatic disorder	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Prostatic haemorrhage	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Prostatism	0/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		2/2316 (0.1%)
Prostatitis	2/2297 (0.1%)		1/2283 (0%)		1/2305 (0%)		2/2316 (0.1%)
Prostatomegaly	1/2297 (0%)		0/2283 (0%)		6/2305 (0.3%)		2/2316 (0.1%)
Rectocele	2/2297 (0.1%)		7/2283 (0.3%)		1/2305 (0%)		4/2316 (0.2%)
Testicular infarction	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Testicular mass	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Testicular pain	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Testicular swelling	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Uterine cervical laceration	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Uterine haemorrhage	2/2297 (0.1%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Uterine polyp	3/2297 (0.1%)		2/2283 (0.1%)		0/2305 (0%)		3/2316 (0.1%)
Uterine prolapse	5/2297 (0.2%)		5/2283 (0.2%)		7/2305 (0.3%)		11/2316 (0.5%)
Uterovaginal prolapse	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		2/2316 (0.1%)
Vaginal haemorrhage	0/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		1/2316 (0%)
Vaginal laceration	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Vaginal prolapse	3/2297 (0.1%)		8/2283 (0.4%)		2/2305 (0.1%)		7/2316 (0.3%)
Vaginal ulceration	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema	4/2297 (0.2%)		2/2283 (0.1%)		1/2305 (0%)		5/2316 (0.2%)
Acute respiratory failure	4/2297 (0.2%)		2/2283 (0.1%)		1/2305 (0%)		4/2316 (0.2%)
Alveolitis allergic	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Anoxia	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Apnoea	0/2297 (0%)		2/2283 (0.1%)		0/2305 (0%)		0/2316 (0%)
Asphyxia	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Aspiration	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Asthma	13/2297 (0.6%)		6/2283 (0.3%)		8/2305 (0.3%)		6/2316 (0.3%)
Atelectasis	1/2297 (0%)		0/2283 (0%)		3/2305 (0.1%)		3/2316 (0.1%)
Brain hypoxia	0/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		0/2316 (0%)
Bronchial hyperreactivity	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Bronchial secretion retention	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Bronchial wall thickening	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Bronchitis chronic	2/2297 (0.1%)		1/2283 (0%)		1/2305 (0%)		2/2316 (0.1%)
Bronchopneumopathy	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Bronchospasm	2/2297 (0.1%)		1/2283 (0%)		0/2305 (0%)		2/2316 (0.1%)
Bullous lung disease	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Chronic obstructive pulmonary disease	21/2297 (0.9%)		10/2283 (0.4%)		18/2305 (0.8%)		18/2316 (0.8%)
Cough	2/2297 (0.1%)		3/2283 (0.1%)		4/2305 (0.2%)		3/2316 (0.1%)
Diaphragmatic hernia	2/2297 (0.1%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Diaphragmatic paralysis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Dyspnoea	18/2297 (0.8%)		15/2283 (0.7%)		28/2305 (1.2%)		16/2316 (0.7%)
Dyspnoea exertional	2/2297 (0.1%)		1/2283 (0%)		2/2305 (0.1%)		0/2316 (0%)
Emphysema	2/2297 (0.1%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Epistaxis	4/2297 (0.2%)		3/2283 (0.1%)		3/2305 (0.1%)		4/2316 (0.2%)
Haemoptysis	0/2297 (0%)		2/2283 (0.1%)		3/2305 (0.1%)		5/2316 (0.2%)
Haemothorax	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Hydropneumothorax	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Hydrothorax	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Hypercapnia	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Hyperventilation	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Hypoventilation	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Hypoxia	1/2297 (0%)		3/2283 (0.1%)		1/2305 (0%)		2/2316 (0.1%)
Idiopathic pulmonary fibrosis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Interstitial lung disease	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Laryngeal polyp	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Laryngeal stenosis	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Laryngospasm	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Lung consolidation	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Lung disorder	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Lung infiltration	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Mediastinal mass	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Nasal polyps	4/2297 (0.2%)		1/2283 (0%)		0/2305 (0%)		3/2316 (0.1%)
Nasal septum deviation	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		2/2316 (0.1%)
Nasal turbinate hypertrophy	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Obstructive airways disorder	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Orthopnoea	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Paranasal cyst	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Pharyngeal polyp	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Pickwickian syndrome	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		2/2316 (0.1%)
Pleural effusion	4/2297 (0.2%)		3/2283 (0.1%)		9/2305 (0.4%)		3/2316 (0.1%)
Pleurisy	0/2297 (0%)		0/2283 (0%)		3/2305 (0.1%)		1/2316 (0%)
Pleuritic pain	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Pneumonia aspiration	2/2297 (0.1%)		0/2283 (0%)		2/2305 (0.1%)		2/2316 (0.1%)
Pneumonitis	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Pneumothorax	1/2297 (0%)		1/2283 (0%)		2/2305 (0.1%)		6/2316 (0.3%)
Pulmonary congestion	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Pulmonary embolism	20/2297 (0.9%)		17/2283 (0.7%)		12/2305 (0.5%)		9/2316 (0.4%)
Pulmonary fibrosis	2/2297 (0.1%)		0/2283 (0%)		2/2305 (0.1%)		1/2316 (0%)
Pulmonary haemorrhage	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Pulmonary hilum mass	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Pulmonary hypertension	1/2297 (0%)		2/2283 (0.1%)		4/2305 (0.2%)		1/2316 (0%)
Pulmonary oedema	4/2297 (0.2%)		6/2283 (0.3%)		7/2305 (0.3%)		6/2316 (0.3%)
Rales	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Respiratory arrest	1/2297 (0%)		1/2283 (0%)		2/2305 (0.1%)		1/2316 (0%)
Respiratory distress	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		2/2316 (0.1%)
Respiratory failure	8/2297 (0.3%)		8/2283 (0.4%)		11/2305 (0.5%)		8/2316 (0.3%)
Restrictive pulmonary disease	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Sinus polyp	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Sleep apnoea syndrome	4/2297 (0.2%)		0/2283 (0%)		5/2305 (0.2%)		4/2316 (0.2%)
Sputum discoloured	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Sputum retention	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Status asthmaticus	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Tonsillar hypertrophy	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Tracheal stenosis	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Upper airway obstruction	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Vocal cord disorder	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Vocal cord polyp	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Wheezing	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Skin and subcutaneous tissue disorders
Actinic keratosis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Angioedema	2/2297 (0.1%)		2/2283 (0.1%)		2/2305 (0.1%)		0/2316 (0%)
Decubitus ulcer	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Dermal cyst	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Dermatitis	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Dermatitis allergic	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Erythema multiforme	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Erythema nodosum	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Excessive granulation tissue	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Hyperhidrosis	0/2297 (0%)		2/2283 (0.1%)		1/2305 (0%)		1/2316 (0%)
Hypoaesthesia facial	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Panniculitis	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Petechiae	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Photodermatosis	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Pityriasis rubra pilaris	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Prurigo	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Pruritus generalised	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Psoriasis	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		2/2316 (0.1%)
Purpura	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Rash	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Rash pruritic	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Scar	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Skin hypertrophy	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Skin lesion	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Skin necrosis	0/2297 (0%)		2/2283 (0.1%)		0/2305 (0%)		0/2316 (0%)
Skin ulcer	4/2297 (0.2%)		2/2283 (0.1%)		0/2305 (0%)		4/2316 (0.2%)
Stasis dermatitis	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Stevens-Johnson syndrome	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Swelling face	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Urticaria	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Social circumstances
Activities of daily living impaired	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Exposure to chemical pollution	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Victim of crime	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Vascular disorders
Aneurysm	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Aneurysm ruptured	0/2297 (0%)		2/2283 (0.1%)		0/2305 (0%)		0/2316 (0%)
Aortic aneurysm	5/2297 (0.2%)		10/2283 (0.4%)		14/2305 (0.6%)		13/2316 (0.6%)
Aortic aneurysm rupture	3/2297 (0.1%)		1/2283 (0%)		1/2305 (0%)		3/2316 (0.1%)
Aortic arteriosclerosis	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Aortic dilatation	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Aortic dissection	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Aortic intramural haematoma	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Aortic rupture	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Aortic stenosis	4/2297 (0.2%)		5/2283 (0.2%)		2/2305 (0.1%)		3/2316 (0.1%)
Arterial disorder	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Arterial haemorrhage	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Arterial insufficiency	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Arterial occlusive disease	1/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Arterial rupture	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Arterial stenosis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Arterial thrombosis	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Arterial thrombosis limb	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Arteriosclerosis	5/2297 (0.2%)		9/2283 (0.4%)		4/2305 (0.2%)		3/2316 (0.1%)
Arteriosclerosis obliterans	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Arteritis	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Artery dissection	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Circulatory collapse	9/2297 (0.4%)		11/2283 (0.5%)		11/2305 (0.5%)		4/2316 (0.2%)
Deep vein thrombosis	12/2297 (0.5%)		7/2283 (0.3%)		13/2305 (0.6%)		13/2316 (0.6%)
Diabetic vascular disorder	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Embolism	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Essential hypertension	1/2297 (0%)		2/2283 (0.1%)		2/2305 (0.1%)		4/2316 (0.2%)
Exsanguination	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Extremity necrosis	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Femoral arterial stenosis	0/2297 (0%)		2/2283 (0.1%)		0/2305 (0%)		1/2316 (0%)
Femoral artery occlusion	0/2297 (0%)		1/2283 (0%)		1/2305 (0%)		2/2316 (0.1%)
Flushing	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Haematoma	2/2297 (0.1%)		5/2283 (0.2%)		0/2305 (0%)		2/2316 (0.1%)
Haemodynamic instability	2/2297 (0.1%)		1/2283 (0%)		0/2305 (0%)		2/2316 (0.1%)
Haemorrhage	3/2297 (0.1%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Haemorrhagic infarction	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Hot flush	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Hypertension	19/2297 (0.8%)		15/2283 (0.7%)		35/2305 (1.5%)		27/2316 (1.2%)
Hypertensive crisis	12/2297 (0.5%)		13/2283 (0.6%)		13/2305 (0.6%)		10/2316 (0.4%)
Hypertensive emergency	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Hypoperfusion	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Hypotension	22/2297 (1%)		19/2283 (0.8%)		21/2305 (0.9%)		12/2316 (0.5%)
Hypovolaemic shock	0/2297 (0%)		2/2283 (0.1%)		4/2305 (0.2%)		0/2316 (0%)
Iliac artery embolism	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Iliac artery occlusion	1/2297 (0%)		1/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Iliac artery stenosis	1/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		1/2316 (0%)
Intermittent claudication	5/2297 (0.2%)		6/2283 (0.3%)		11/2305 (0.5%)		9/2316 (0.4%)
Ischaemia	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Leriche syndrome	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Peripheral arterial occlusive disease	5/2297 (0.2%)		2/2283 (0.1%)		6/2305 (0.3%)		4/2316 (0.2%)
Peripheral artery aneurysm	2/2297 (0.1%)		3/2283 (0.1%)		2/2305 (0.1%)		0/2316 (0%)
Peripheral embolism	1/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		0/2316 (0%)
Peripheral ischaemia	0/2297 (0%)		2/2283 (0.1%)		5/2305 (0.2%)		2/2316 (0.1%)
Peripheral vascular disorder	0/2297 (0%)		1/2283 (0%)		4/2305 (0.2%)		5/2316 (0.2%)
Poor peripheral circulation	1/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Post thrombotic syndrome	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Shock	2/2297 (0.1%)		1/2283 (0%)		1/2305 (0%)		1/2316 (0%)
Shock haemorrhagic	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Subclavian artery stenosis	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Subclavian steal syndrome	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Subclavian vein thrombosis	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Superior vena caval occlusion	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Temporal arteritis	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Thromboangiitis obliterans	0/2297 (0%)		0/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Thrombophlebitis	0/2297 (0%)		0/2283 (0%)		2/2305 (0.1%)		4/2316 (0.2%)
Thrombosis	1/2297 (0%)		2/2283 (0.1%)		3/2305 (0.1%)		1/2316 (0%)
Varicose vein	4/2297 (0.2%)		3/2283 (0.1%)		5/2305 (0.2%)		4/2316 (0.2%)
Vasculitis	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Vasodilatation	0/2297 (0%)		1/2283 (0%)		0/2305 (0%)		2/2316 (0.1%)
Vein pain	1/2297 (0%)		0/2283 (0%)		0/2305 (0%)		0/2316 (0%)
Venous insufficiency	0/2297 (0%)		2/2283 (0.1%)		0/2305 (0%)		0/2316 (0%)
Venous occlusion	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		0/2316 (0%)
Venous thrombosis	0/2297 (0%)		0/2283 (0%)		1/2305 (0%)		2/2316 (0.1%)
Venous thrombosis limb	4/2297 (0.2%)		1/2283 (0%)		0/2305 (0%)		1/2316 (0%)
Other (Not Including Serious) Adverse Events
	Valsartan 160 mg od + Nateglinide 60 mg ac		Valsartan 160 mg od + Placebo Nateglinide		Nateglinide 60 mg ac + Placebo Valsartan		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1970/2297 (85.8%)		1932/2283 (84.6%)		1951/2305 (84.6%)		1934/2316 (83.5%)
Cardiac disorders
Angina pectoris	114/2297 (5%)		110/2283 (4.8%)		125/2305 (5.4%)		119/2316 (5.1%)
Ear and labyrinth disorders
Vertigo	106/2297 (4.6%)		117/2283 (5.1%)		108/2305 (4.7%)		100/2316 (4.3%)
Eye disorders
Cataract	148/2297 (6.4%)		160/2283 (7%)		146/2305 (6.3%)		163/2316 (7%)
Gastrointestinal disorders
Abdominal pain	128/2297 (5.6%)		118/2283 (5.2%)		134/2305 (5.8%)		134/2316 (5.8%)
Abdominal pain upper	142/2297 (6.2%)		126/2283 (5.5%)		124/2305 (5.4%)		126/2316 (5.4%)
Constipation	108/2297 (4.7%)		95/2283 (4.2%)		127/2305 (5.5%)		135/2316 (5.8%)
Diarrhoea	305/2297 (13.3%)		299/2283 (13.1%)		278/2305 (12.1%)		277/2316 (12%)
Dyspepsia	142/2297 (6.2%)		142/2283 (6.2%)		152/2305 (6.6%)		147/2316 (6.3%)
Nausea	197/2297 (8.6%)		176/2283 (7.7%)		181/2305 (7.9%)		193/2316 (8.3%)
General disorders
Fatigue	234/2297 (10.2%)		202/2283 (8.8%)		222/2305 (9.6%)		228/2316 (9.8%)
Non-cardiac chest pain	120/2297 (5.2%)		116/2283 (5.1%)		128/2305 (5.6%)		126/2316 (5.4%)
Oedema peripheral	228/2297 (9.9%)		198/2283 (8.7%)		264/2305 (11.5%)		284/2316 (12.3%)
Infections and infestations
Bronchitis	218/2297 (9.5%)		234/2283 (10.2%)		249/2305 (10.8%)		226/2316 (9.8%)
Influenza	301/2297 (13.1%)		309/2283 (13.5%)		299/2305 (13%)		315/2316 (13.6%)
Nasopharyngitis	396/2297 (17.2%)		410/2283 (18%)		408/2305 (17.7%)		385/2316 (16.6%)
Sinusitis	127/2297 (5.5%)		122/2283 (5.3%)		134/2305 (5.8%)		138/2316 (6%)
Upper respiratory tract infection	270/2297 (11.8%)		274/2283 (12%)		250/2305 (10.8%)		278/2316 (12%)
Urinary tract infection	202/2297 (8.8%)		190/2283 (8.3%)		225/2305 (9.8%)		207/2316 (8.9%)
Metabolism and nutrition disorders
Hypercholesterolaemia	115/2297 (5%)		122/2283 (5.3%)		137/2305 (5.9%)		110/2316 (4.7%)
Hypoglycaemia	455/2297 (19.8%)		271/2283 (11.9%)		454/2305 (19.7%)		251/2316 (10.8%)
Musculoskeletal and connective tissue disorders
Arthralgia	369/2297 (16.1%)		377/2283 (16.5%)		377/2305 (16.4%)		367/2316 (15.8%)
Back pain	398/2297 (17.3%)		358/2283 (15.7%)		339/2305 (14.7%)		326/2316 (14.1%)
Musculoskeletal pain	158/2297 (6.9%)		163/2283 (7.1%)		141/2305 (6.1%)		151/2316 (6.5%)
Osteoarthritis	226/2297 (9.8%)		194/2283 (8.5%)		224/2305 (9.7%)		241/2316 (10.4%)
Pain in extremity	280/2297 (12.2%)		273/2283 (12%)		275/2305 (11.9%)		238/2316 (10.3%)
Nervous system disorders
Dizziness	440/2297 (19.2%)		379/2283 (16.6%)		397/2305 (17.2%)		351/2316 (15.2%)
Headache	242/2297 (10.5%)		289/2283 (12.7%)		306/2305 (13.3%)		311/2316 (13.4%)
Psychiatric disorders
Depression	146/2297 (6.4%)		165/2283 (7.2%)		169/2305 (7.3%)		158/2316 (6.8%)
Insomnia	117/2297 (5.1%)		94/2283 (4.1%)		100/2305 (4.3%)		115/2316 (5%)
Respiratory, thoracic and mediastinal disorders
Cough	238/2297 (10.4%)		220/2283 (9.6%)		234/2305 (10.2%)		224/2316 (9.7%)
Dyspnoea	122/2297 (5.3%)		124/2283 (5.4%)		152/2305 (6.6%)		146/2316 (6.3%)
Vascular disorders
Hypertension	293/2297 (12.8%)		302/2283 (13.2%)		392/2305 (17%)		444/2316 (19.2%)
Hypotension	732/2297 (31.9%)		717/2283 (31.4%)		582/2305 (25.2%)		542/2316 (23.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.