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Clinical Trial Results:
A Multinational, Randomised, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Ticagrelor twice daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Stroke in Patients with Type 2 Diabetes Mellitus

Summary
EudraCT number	2013-003519-23
Trial protocol	HU CZ SK SE NL DE IT GB ES NO AT DK BE FI BG FR
Global end of trial date	16 Feb 2019

Results information
Results version number	v2(current)
This version publication date	06 May 2020
First version publication date	26 Jan 2020
Other versions	v1
Version creation reason

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

D513BC00001

ISRCTN number

-

US NCT number

NCT01991795

WHO universal trial number (UTN)

-

Sponsor organisation name

AstraZeneca

Sponsor organisation address

Pepparedsleden 1, Mölndal, Sweden, 43183

Public contact

Global Clinical Lead, Study Information center, +1 877 240 9479, information.center@astrazeneca.com

Scientific contact

Global Clinical Lead, Study Information center, +1 877 240 9479, information.center@astrazeneca.com

Is trial part of an agreed paediatric investigation plan (PIP)

No

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Analysis stage

Final

Date of interim/final analysis

16 Feb 2019

Is this the analysis of the primary completion data?

Yes

Primary completion date

16 Feb 2019

Global end of trial reached?

Yes

Global end of trial date

16 Feb 2019

Was the trial ended prematurely?

No

Main objective of the trial

The primary objective of the study is to compare the effect of long-term treatment with ticagrelor twice daily (bd) vs. placebo for the prevention of major cardiovascular (CV) events (composite of CV death, myocardial infarction [MI] or stroke) in patients with Type 2 Diabetes Mellitus (T2DM) at high risk for CV events, but without a previous medical history of MI or stroke. The primary efficacy variable is time from randomisation to first occurrence of any event from the composite of CV death, MI or stroke (ischaemic, haemorrhagic or unknown etiology).

Protection of trial subjects

Treated in routine care, on a background therapy of acetylsalicylic acid (ASA).

Background therapy

Patients should be treated with low-dose acetylsalicylic acid (ASA) unless contraindicated or not tolerated, in accordance with national and international clinical practice guidelines.

Evidence for comparator

-

Actual start date of recruitment

10 Feb 2014

Long term follow-up planned

Yes

Long term follow-up rationale

Efficacy, Safety

Long term follow-up duration

40 Months

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Slovakia: 244

Country: Number of subjects enrolled

South Africa: 299

Country: Number of subjects enrolled

Spain: 340

Country: Number of subjects enrolled

Sweden: 224

Country: Number of subjects enrolled

Taiwan: 803

Country: Number of subjects enrolled

Thailand: 231

Country: Number of subjects enrolled

Turkey: 225

Country: Number of subjects enrolled

Ukraine: 792

Country: Number of subjects enrolled

United Kingdom: 246

Country: Number of subjects enrolled

United States: 2266

Country: Number of subjects enrolled

Vietnam: 254

Country: Number of subjects enrolled

Argentina: 394

Country: Number of subjects enrolled

Australia: 188

Country: Number of subjects enrolled

Austria: 87

Country: Number of subjects enrolled

Belgium: 217

Country: Number of subjects enrolled

Brazil: 811

Country: Number of subjects enrolled

Bulgaria: 878

Country: Number of subjects enrolled

Canada: 729

Country: Number of subjects enrolled

Chile: 300

Country: Number of subjects enrolled

China: 910

Country: Number of subjects enrolled

Colombia: 136

Country: Number of subjects enrolled

Czech Republic: 602

Country: Number of subjects enrolled

Denmark: 243

Country: Number of subjects enrolled

Finland: 118

Country: Number of subjects enrolled

France: 172

Country: Number of subjects enrolled

Germany: 547

Country: Number of subjects enrolled

Hong Kong: 152

Country: Number of subjects enrolled

Hungary: 616

Country: Number of subjects enrolled

India: 292

Country: Number of subjects enrolled

Israel: 117

Country: Number of subjects enrolled

Italy: 130

Country: Number of subjects enrolled

Japan: 496

Country: Number of subjects enrolled

Korea, Republic of: 870

Country: Number of subjects enrolled

Mexico: 364

Country: Number of subjects enrolled

Netherlands: 479

Country: Number of subjects enrolled

Norway: 191

Country: Number of subjects enrolled

Peru: 173

Country: Number of subjects enrolled

Philippines: 92

Country: Number of subjects enrolled

Poland: 1636

Country: Number of subjects enrolled

Romania: 80

Country: Number of subjects enrolled

Russian Federation: 1121

Country: Number of subjects enrolled

Saudi Arabia: 155

Worldwide total number of subjects

19220

EEA total number of subjects

7050

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

7934

From 65 to 84 years

11115

85 years and over

171

Subject disposition

Top of page

Recruitment details

In total, 20108 patients were enrolled, 19220 patients were randomised to study drug and included in the analyses, from 1315 study sites in 42 countries. The first patient was enrolled on 10 February 2014. The last patient visit took place on 25 January 2019.

Screening details

Enrolled patients randomised to study drug 95.8%; n =19271, of which 51 patients were randomised to study drug at a site prematurely closed by sponsor and excluded from the study results. Patients who were not randomised 4.2%; n=837. Patient did not meet inclusion/exclusion criteria n=454, Patient decision n=256, Death n=1, Other reason n=131.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Carer, Data analyst, Assessor

Are arms mutually exclusive

Yes

Ticagrelor 60 mg

Arm description

Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.

Arm type

Experimental

Investigational medicinal product name

Ticegrelor 90mg film-coated tablets

Investigational medicinal product code

Other name

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

90 mg twice daily

Investigational medicinal product name

Ticagrelor 60mg film-coated tablets

Investigational medicinal product code

Other name

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

60 mg twice daily

Ticagrelor placebo

Arm description

Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.

Arm type

Placebo

Investigational medicinal product name

Ticagrelor 60 mg placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Matching 60mg ticagrelor placebo twice daily

Investigational medicinal product name

Ticagrelor 90 mg placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Matching 90mg ticagrelor placebo twice daily

Number of subjects in period 1	Ticagrelor 60 mg	Ticagrelor placebo
Started	9619	9601
Completed	9496	9503
Not completed	123	98
Consent withdrawn by subject	117	94
Lost to follow-up	6	4

Baseline characteristics

Top of page

Reporting group title

Ticagrelor 60 mg

Reporting group description

Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.

Reporting group title

Ticagrelor placebo

Reporting group description

Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.

Reporting group values	Ticagrelor 60 mg	Ticagrelor placebo	Total
Number of subjects	9619	9601	19220
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	3975	3959	7934
From 65-84 years	5560	5555	11115
85 years and over	84	87	171
Age Continuous
Units: Years
arithmetic mean (standard deviation)	66.3 ( 7.8 )	66.3 ( 7.7 )	-
Sex: Female, Male
Units: Subjects
Male	6576	6613	13189
Female	3043	2988	6031
Region of Enrollment
Units: Subjects
ARG	195	199	394
AUS	94	94	188
AUT	42	45	87
BEL	109	108	217
BGR	435	443	878
BRA	412	399	811
CAN	364	365	729
CHL	152	148	300
CHN	456	454	910
COL	68	68	136
CZE	304	298	602
DEU	277	270	547
DNK	123	120	243
ESP	170	170	340
FIN	60	58	118
FRA	85	87	172
GBR	123	123	246
HKG	76	76	152
HUN	306	310	616
IND	147	145	292
ISR	60	57	117
ITA	67	63	130
JPN	246	250	496
KOR	433	437	870
MEX	182	182	364
NLD	242	237	479
NOR	95	96	191
PER	91	82	173
PHL	47	45	92
POL	815	821	1636
ROU	37	43	80
RUS	561	560	1121
SAU	79	76	155
SVK	122	122	244
SWE	110	114	224
THA	115	116	231
TUR	113	112	225
TWN	402	401	803
UKR	399	393	792
USA	1126	1140	2266
VNM	129	125	254
ZAF	150	149	299
Race/Ethnicity, Customized
Units: Subjects
White	6838	6858	13696
Black or african american	205	198	403
Asian	2211	2195	4406
Native hawaiian or other pacific islander	7	7	14
American indian or alaska native	161	152	313
Other	197	191	388

End points

Top of page

Reporting group title

Ticagrelor 60 mg

Reporting group description

Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.

Reporting group title

Ticagrelor placebo

Reporting group description

Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.

Primary: Composite of Cardiovascular (CV) Death, MI or Stroke

Top of page

End point title

Composite of Cardiovascular (CV) Death, MI or Stroke

End point description

Participants with Cardiovascular (CV) death, myocardial infarction (MI) or stroke. If no event, censoring occurs at the earliest of PACD, last endpoint assessment date and non-CV death date.

End point type

Primary

End point timeframe

From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.

End point values	Ticagrelor 60 mg	Ticagrelor placebo
Number of subjects analysed	9619	9601
Units: Number of participants with event	736	818

Prevention of composite of CV death, MI or stroke

Statistical analysis description

Time to first occurrence of any event from the composite of CV death, MI or stroke.

Comparison groups

Ticagrelor 60 mg v Ticagrelor placebo

Number of subjects included in analysis

19220

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0378 ^[1]

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.81

upper limit

0.99

Notes
[1] - The hypothesis will be tested at the 4.96% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing

Secondary: CV death

Top of page

End point title

CV death

End point description

Participants with Cardiovascular (CV) death. If no event, censoring occurs at the earliest of PACD, last endpoint assessment date and non-CV death date.

End point type

Secondary

End point timeframe

From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.

End point values	Ticagrelor 60 mg	Ticagrelor placebo
Number of subjects analysed	9619	9601
Units: Number of participants with event	364	357

Prevention of CV death

Statistical analysis description

Time from randomisation to death of CV cause

Comparison groups

Ticagrelor 60 mg v Ticagrelor placebo

Number of subjects included in analysis

19220

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7883 ^[2]

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

1.02

Confidence interval

level

95%

sides

2-sided

lower limit

0.88

upper limit

1.18

Notes
[2] - The hypothesis will be tested at the 4.96% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing

Secondary: MI

Top of page

End point title

MI

End point description

Participants with myocardial infarction. If no event, censoring occurs at the earliest of primary analysis censoring date (PACD), last endpoint assessment date and death date

End point type

Secondary

End point timeframe

From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.

End point values	Ticagrelor 60 mg	Ticagrelor placebo
Number of subjects analysed	9619	9601
Units: Number of participants with event	274	328

Prevention of MI

Statistical analysis description

Time from randomisation to first occurrence of MI.

Comparison groups

Ticagrelor 60 mg v Ticagrelor placebo

Number of subjects included in analysis

19220

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0294 ^[3]

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

0.84

Confidence interval

level

95%

sides

2-sided

lower limit

0.71

upper limit

0.98

Notes
[3] - The hypothesis will be tested at the 4.96% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing

Secondary: Ischaemic stroke

Top of page

End point title

Ischaemic stroke

End point description

Participants with ischaemic stroke. If no event, censoring occurs at the earliest of PACD, last endpoint assessment date and death date.

End point type

Secondary

End point timeframe

From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.

End point values	Ticagrelor 60 mg	Ticagrelor placebo
Number of subjects analysed	9619	9601
Units: Number of participants with event	152	191

Prevention of ischaemic stroke

Statistical analysis description

Time from randomisation to first occurrence of ischaemic stroke

Comparison groups

Ticagrelor 60 mg v Ticagrelor placebo

Number of subjects included in analysis

19220

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0375 ^[4]

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

0.8

Confidence interval

level

95%

sides

2-sided

lower limit

0.64

upper limit

0.99

Notes
[4] - The hypothesis will be tested at the 4.96% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing

Secondary: All-cause death

Top of page

End point title

All-cause death

End point description

Participants with all-cause death. If no event, censoring occurs at the earliest of PACD and last endpoint assessment date. Includes deaths based on publically available vital status data in patients who have withdrawn consent.

End point type

Secondary

End point timeframe

From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.

End point values	Ticagrelor 60 mg	Ticagrelor placebo
Number of subjects analysed	9619	9601
Units: Number of participants with event	579	592

Prevention of all-cause death

Statistical analysis description

Time from randomisation to death of any cause

Comparison groups

Ticagrelor 60 mg v Ticagrelor placebo

Number of subjects included in analysis

19220

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6846

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

0.98

Confidence interval

level

95%

sides

2-sided

lower limit

0.87

upper limit

1.1

Other pre-specified: TIMI Major bleeding event (primary safety objective)

Top of page

End point title

TIMI Major bleeding event (primary safety objective)

End point description

Participants with TIMI major bleeding event. If no event, censoring occurs at the earliest of last endpoint assessment date, death date and 7 days following the date of last dose of study medication

End point type

Other pre-specified

End point timeframe

From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

End point values	Ticagrelor 60 mg	Ticagrelor placebo
Number of subjects analysed	9562 ^[5]	9531 ^[6]
Units: Number of participants with event	206	100

Notes
[5] - Safety analyses included subjects who received at least 1 dose of randomised ticagrelor or placebo
[6] - Safety analyses included subjects who received at least 1 dose of randomised ticagrelor or placebo

TIMI major bleeding

Statistical analysis description

Time to first TIMI major bleeding event

Comparison groups

Ticagrelor 60 mg v Ticagrelor placebo

Number of subjects included in analysis

19093

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.0001

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

2.32

Confidence interval

level

95%

sides

2-sided

lower limit

1.82

upper limit

2.94

Other pre-specified: TIMI major or minor bleeding event

Top of page

End point title

TIMI major or minor bleeding event

End point description

Participants with TIMI major or minor bleeding event. If no event, censoring occurs at the earliest of last endpoint assessment date, death date and 7 days following the date of last dose of study medication

End point type

Other pre-specified

End point timeframe

From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

End point values	Ticagrelor 60 mg	Ticagrelor placebo
Number of subjects analysed	9562 ^[7]	9531 ^[8]
Units: Number of participants with event	285	129

Notes
[7] - Safety analyses included subjects who received at least 1 dose of randomised ticagrelor or placebo
[8] - Safety analyses included subjects who received at least 1 dose of randomised ticagrelor or placebo

TIMI major or minor bleeding

Statistical analysis description

Time to first TIMI major or minor bleeding

Comparison groups

Ticagrelor 60 mg v Ticagrelor placebo

Number of subjects included in analysis

19093

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.0001

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

2.49

Confidence interval

level

95%

sides

2-sided

lower limit

2.02

upper limit

3.07

Other pre-specified: PLATO major bleeding event

Top of page

End point title

PLATO major bleeding event

End point description

Participants with PLATO major bleeding event. If no event, censoring occurs at the earliest of last endpoint assessment date, death date and 7 days following the date of last dose of study medication

End point type

Other pre-specified

End point timeframe

From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

End point values	Ticagrelor 60 mg	Ticagrelor placebo
Number of subjects analysed	9562 ^[9]	9531 ^[10]
Units: Number of participants with event	310	145

Notes
[9] - Safety analyses included subjects who received at least 1 dose of randomised ticagrelor or placebo
[10] - Safety analyses included subjects who received at least 1 dose of randomised ticagrelor or placebo

PLATO major bleeding

Statistical analysis description

Time to first PLATO major bleeding

Comparison groups

Ticagrelor 60 mg v Ticagrelor placebo

Number of subjects included in analysis

19093

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.0001

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

2.41

Confidence interval

level

95%

sides

2-sided

lower limit

1.98

upper limit

2.93

Other pre-specified: Permanent discontinuation of study medication due to any bleeding event

Top of page

End point title

Permanent discontinuation of study medication due to any bleeding event

End point description

Participants with permanent discontinuation of study medication due to any bleeding event. If no event, censoring occurs at the earliest of last endpoint assessment date, death date and the date of last dose of study medication

End point type

Other pre-specified

End point timeframe

From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

End point values	Ticagrelor 60 mg	Ticagrelor placebo
Number of subjects analysed	9562 ^[11]	9531 ^[12]
Units: Number of participants with event	466	125

Notes
[11] - Safety analyses included subjects who received at least 1 dose of randomised ticagrelor or placebo
[12] - Safety analyses included subjects who received at least 1 dose of randomised ticagrelor or placebo

Permanent discontinuation of IP due to bleeding

Statistical analysis description

Time to permanent discontinuation of study medication due to any bleeding event

Comparison groups

Ticagrelor 60 mg v Ticagrelor placebo

Number of subjects included in analysis

19093

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.0001

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

4.04

Confidence interval

level

95%

sides

2-sided

lower limit

3.32

upper limit

4.92

Adverse events

Top of page

Timeframe for reporting adverse events

From Randomisation until last dose of study drug + 7 days

Adverse event reporting additional description

Systematic assessment of suspected bleeding events, suspected endpoint events, serious adverse events, adverse events that leads to permanent discontinuation of study medication and non-serious AEs of interest (ie, dyspnoea, renal impairment, bradyarrhythmia, gout, and pneumonia),

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

21.1

Reporting group title

Ticagrelor

Reporting group description

-

Reporting group title

Placebo

Reporting group description

-

Serious adverse events	Ticagrelor	Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	3049 / 9562 (31.89%)	3210 / 9531 (33.68%)
number of deaths (all causes)	187	223
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal neoplasm
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acute myeloid leukaemia
subjects affected / exposed	2 / 9562 (0.02%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 2
Acute promyelocytic leukaemia
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Adenocarcinoma
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Adenocarcinoma gastric
subjects affected / exposed	3 / 9562 (0.03%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	1 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Adenocarcinoma of colon
subjects affected / exposed	14 / 9562 (0.15%)	6 / 9531 (0.06%)
occurrences causally related to treatment / all	0 / 14	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Adenocarcinoma pancreas
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Adrenal adenoma
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Adrenal neoplasm
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anal cancer
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
B-cell lymphoma
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Basal cell carcinoma
subjects affected / exposed	5 / 9562 (0.05%)	9 / 9531 (0.09%)
occurrences causally related to treatment / all	1 / 6	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Benign gastric neoplasm
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Benign neoplasm of bladder
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Benign neoplasm of thyroid gland
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Benign ovarian tumour
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bile duct cancer
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Bladder cancer
subjects affected / exposed	8 / 9562 (0.08%)	9 / 9531 (0.09%)
occurrences causally related to treatment / all	0 / 8	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 1
Bladder cancer recurrent
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder neoplasm
subjects affected / exposed	3 / 9562 (0.03%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder transitional cell carcinoma
subjects affected / exposed	2 / 9562 (0.02%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	1 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Bone cancer metastatic
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bowen's disease
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Brain neoplasm
subjects affected / exposed	3 / 9562 (0.03%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Brain neoplasm malignant
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Breast cancer
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cancer female
subjects affected / exposed	9 / 9562 (0.09%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 9	0 / 4
deaths causally related to treatment / all	0 / 3	0 / 0
Breast cancer metastatic
subjects affected / exposed	1 / 9562 (0.01%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Breast neoplasm
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchial carcinoma
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Carcinoid tumour
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebellopontine angle tumour
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cervix carcinoma recurrent
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Cervix carcinoma stage 0
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cholangiocarcinoma
subjects affected / exposed	3 / 9562 (0.03%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 2	0 / 1
Cholesteatoma
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chordoma
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic lymphocytic leukaemia
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic myeloid leukaemia
subjects affected / exposed	3 / 9562 (0.03%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	1 / 3	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Clear cell renal cell carcinoma
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colon adenoma
subjects affected / exposed	3 / 9562 (0.03%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Colon cancer
subjects affected / exposed	12 / 9562 (0.13%)	16 / 9531 (0.17%)
occurrences causally related to treatment / all	0 / 12	0 / 16
deaths causally related to treatment / all	0 / 1	0 / 0
Colon cancer metastatic
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 2
Colon neoplasm
subjects affected / exposed	2 / 9562 (0.02%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Colorectal adenocarcinoma
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colorectal cancer
subjects affected / exposed	0 / 9562 (0.00%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Cutaneous lymphoma
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endometrial adenocarcinoma
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Endometrial cancer
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	1 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endometrial cancer metastatic
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fibroadenoma of breast
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fibrosarcoma
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fibrous histiocytoma
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gallbladder adenocarcinoma
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gallbladder adenoma
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gallbladder cancer
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gallbladder neoplasm
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Gastric adenoma
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric cancer
subjects affected / exposed	7 / 9562 (0.07%)	10 / 9531 (0.10%)
occurrences causally related to treatment / all	1 / 7	1 / 10
deaths causally related to treatment / all	1 / 1	0 / 3
Gastric neoplasm
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal carcinoma
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal lymphoma
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal melanoma
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Gastrointestinal neoplasm
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Gastrointestinal stromal tumour
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal tract adenoma
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Glioblastoma
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Hepatic cancer
subjects affected / exposed	3 / 9562 (0.03%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 2
Hepatic cancer metastatic
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Hepatobiliary neoplasm
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Hepatocellular carcinoma
subjects affected / exposed	9 / 9562 (0.09%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 10	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 3
Invasive breast carcinoma
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Invasive ductal breast carcinoma
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine benign neoplasm
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngeal cancer
subjects affected / exposed	3 / 9562 (0.03%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngeal neoplasm
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lentigo maligna
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Leukaemia
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Lip and/or oral cavity cancer
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Lip neoplasm malignant stage unspecified
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lipofibroma
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lipoma
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung adenocarcinoma
subjects affected / exposed	3 / 9562 (0.03%)	6 / 9531 (0.06%)
occurrences causally related to treatment / all	0 / 3	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 1
Lung cancer metastatic
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
Lung neoplasm
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lung neoplasm malignant
subjects affected / exposed	14 / 9562 (0.15%)	20 / 9531 (0.21%)
occurrences causally related to treatment / all	0 / 14	1 / 20
deaths causally related to treatment / all	0 / 8	0 / 12
Lymphoma
subjects affected / exposed	2 / 9562 (0.02%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant melanoma
subjects affected / exposed	7 / 9562 (0.07%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 7	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant neoplasm of renal pelvis
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant neoplasm of unknown primary site
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Meningioma
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Meningioma benign
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to bone
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to central nervous system
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Metastases to liver
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Metastases to lung
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to peritoneum
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to pleura
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastatic gastric cancer
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Metastatic malignant melanoma
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Metastatic neoplasm
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Monoclonal gammopathy
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Muscle neoplasm
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal cancer
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myelodysplastic syndrome
subjects affected / exposed	2 / 9562 (0.02%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 2	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Nasopharyngeal cancer
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neoplasm
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neoplasm malignant
subjects affected / exposed	0 / 9562 (0.00%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Neoplasm prostate
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Non-small cell lung cancer
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal adenocarcinoma
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal carcinoma
subjects affected / exposed	0 / 9562 (0.00%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
Oesophageal neoplasm
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oral neoplasm benign
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoma
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian cancer
subjects affected / exposed	2 / 9562 (0.02%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
Ovarian fibroma
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian granulosa cell tumour
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian neoplasm
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic carcinoma
subjects affected / exposed	12 / 9562 (0.13%)	12 / 9531 (0.13%)
occurrences causally related to treatment / all	1 / 13	1 / 12
deaths causally related to treatment / all	0 / 8	1 / 7
Pancreatic carcinoma metastatic
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 2	0 / 1
Pancreatic neoplasm
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 1
Pancreatic neuroendocrine tumour
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic sarcoma
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Papillary cystadenoma lymphomatosum
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Papillary thyroid cancer
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Parathyroid tumour benign
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Penis carcinoma metastatic
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Phyllodes tumour
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pituitary tumour
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pituitary tumour benign
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Plasma cell myeloma
subjects affected / exposed	0 / 9562 (0.00%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Plasmacytoma
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pleomorphic liposarcoma
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pleural neoplasm
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	1 / 1
Prostate cancer
subjects affected / exposed	31 / 9562 (0.32%)	36 / 9531 (0.38%)
occurrences causally related to treatment / all	0 / 31	0 / 36
deaths causally related to treatment / all	0 / 1	0 / 0
Prostate cancer metastatic
subjects affected / exposed	3 / 9562 (0.03%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 3
Prostate cancer recurrent
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
Prostate cancer stage 0
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatic adenoma
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal adenocarcinoma
subjects affected / exposed	2 / 9562 (0.02%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal cancer
subjects affected / exposed	9 / 9562 (0.09%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	1 / 9	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal cancer recurrent
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal neoplasm
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rectosigmoid cancer
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectosigmoid cancer metastatic
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cancer
subjects affected / exposed	3 / 9562 (0.03%)	7 / 9531 (0.07%)
occurrences causally related to treatment / all	0 / 3	1 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cancer metastatic
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Renal cell carcinoma
subjects affected / exposed	5 / 9562 (0.05%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 0
Renal neoplasm
subjects affected / exposed	2 / 9562 (0.02%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Retroperitoneal cancer
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Salivary gland adenoma
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Salivary gland neoplasm
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin cancer
subjects affected / exposed	3 / 9562 (0.03%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Small cell lung cancer
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 2	0 / 1
Small cell lung cancer recurrent
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestine adenocarcinoma
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestine carcinoma
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Soft tissue sarcoma
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Squamous cell carcinoma of lung
subjects affected / exposed	3 / 9562 (0.03%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma of skin
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma of the cervix
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma of the oral cavity
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma of the tongue
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thyroid adenoma
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thyroid cancer
subjects affected / exposed	0 / 9562 (0.00%)	5 / 9531 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 1
Thyroid cancer recurrent
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thyroid neoplasm
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tongue neoplasm malignant stage unspecified
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Tonsil cancer
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Transitional cell cancer of the renal pelvis and ureter
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Transitional cell carcinoma
subjects affected / exposed	4 / 9562 (0.04%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 5	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tumour haemorrhage
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine cancer
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine leiomyoma
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vulval cancer
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
B-cell lymphoma stage I
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder transitional cell carcinoma stage II
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Endometrial cancer stage I
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Endometrial cancer stage II
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Malignant neoplasm papilla of Vater
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Non-Hodgkin's lymphoma
subjects affected / exposed	3 / 9562 (0.03%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer stage III
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Accelerated hypertension
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Air embolism
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Angiopathy
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic aneurysm
subjects affected / exposed	8 / 9562 (0.08%)	9 / 9531 (0.09%)
occurrences causally related to treatment / all	0 / 8	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic arteriosclerosis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic dissection
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic stenosis
subjects affected / exposed	5 / 9562 (0.05%)	7 / 9531 (0.07%)
occurrences causally related to treatment / all	0 / 5	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Arterial occlusive disease
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Arterial stenosis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arterial thrombosis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriosclerosis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Artery dissection
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atherosclerotic plaque rupture
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood pressure inadequately controlled
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Circulatory collapse
subjects affected / exposed	1 / 9562 (0.01%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Deep vein thrombosis
subjects affected / exposed	6 / 9562 (0.06%)	8 / 9531 (0.08%)
occurrences causally related to treatment / all	0 / 6	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic vascular disorder
subjects affected / exposed	1 / 9562 (0.01%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Embolism arterial
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Embolism venous
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Extremity necrosis
subjects affected / exposed	5 / 9562 (0.05%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 6	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertension
subjects affected / exposed	36 / 9562 (0.38%)	45 / 9531 (0.47%)
occurrences causally related to treatment / all	0 / 40	0 / 45
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive crisis
subjects affected / exposed	15 / 9562 (0.16%)	23 / 9531 (0.24%)
occurrences causally related to treatment / all	0 / 17	0 / 25
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive emergency
subjects affected / exposed	4 / 9562 (0.04%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypotension
subjects affected / exposed	9 / 9562 (0.09%)	6 / 9531 (0.06%)
occurrences causally related to treatment / all	0 / 10	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Hypovolaemic shock
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Iliac artery disease
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Iliac artery embolism
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intermittent claudication
subjects affected / exposed	9 / 9562 (0.09%)	7 / 9531 (0.07%)
occurrences causally related to treatment / all	0 / 9	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Labile blood pressure
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphocele
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphoedema
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant hypertension
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Necrosis ischaemic
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neurogenic shock
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Orthostatic hypotension
subjects affected / exposed	7 / 9562 (0.07%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 7	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral arterial occlusive disease
subjects affected / exposed	31 / 9562 (0.32%)	48 / 9531 (0.50%)
occurrences causally related to treatment / all	0 / 38	0 / 60
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery aneurysm
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery occlusion
subjects affected / exposed	2 / 9562 (0.02%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery stenosis
subjects affected / exposed	10 / 9562 (0.10%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 10	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery thrombosis
subjects affected / exposed	5 / 9562 (0.05%)	6 / 9531 (0.06%)
occurrences causally related to treatment / all	0 / 6	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral coldness
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral embolism
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral ischaemia
subjects affected / exposed	14 / 9562 (0.15%)	18 / 9531 (0.19%)
occurrences causally related to treatment / all	0 / 17	0 / 19
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral vascular disorder
subjects affected / exposed	3 / 9562 (0.03%)	5 / 9531 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral venous disease
subjects affected / exposed	3 / 9562 (0.03%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Rheumatoid vasculitis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Shock
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
Shock haemorrhagic
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Subclavian artery stenosis
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subgaleal haematoma
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Temporal arteritis
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombophlebitis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombophlebitis superficial
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombosis
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Varicose vein
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular compression
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular occlusion
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Venous thrombosis limb
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Administration site phlebitis
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Asthenia
subjects affected / exposed	4 / 9562 (0.04%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Capsular contracture associated with breast implant
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac death
subjects affected / exposed	4 / 9562 (0.04%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 4	0 / 1
Catheter site haemorrhage
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chest discomfort
subjects affected / exposed	5 / 9562 (0.05%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chest pain
subjects affected / exposed	6 / 9562 (0.06%)	11 / 9531 (0.12%)
occurrences causally related to treatment / all	1 / 6	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Complication associated with device
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Death
subjects affected / exposed	52 / 9562 (0.54%)	60 / 9531 (0.63%)
occurrences causally related to treatment / all	0 / 52	1 / 60
deaths causally related to treatment / all	0 / 52	1 / 60
Drowning
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Facial pain
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fatigue
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Foreign body reaction
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gait disturbance
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gait inability
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
General physical health deterioration
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Impaired healing
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Medical device site haemorrhage
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mucosal exfoliation
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple organ dysfunction syndrome
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0
Necrobiosis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Necrosis
subjects affected / exposed	2 / 9562 (0.02%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Nodule
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Non-cardiac chest pain
subjects affected / exposed	54 / 9562 (0.56%)	66 / 9531 (0.69%)
occurrences causally related to treatment / all	0 / 60	0 / 72
deaths causally related to treatment / all	0 / 0	0 / 0
Oedema
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oedema peripheral
subjects affected / exposed	1 / 9562 (0.01%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Pacemaker generated arrhythmia
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pain
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral swelling
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	8 / 9562 (0.08%)	6 / 9531 (0.06%)
occurrences causally related to treatment / all	0 / 8	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Sudden cardiac death
subjects affected / exposed	6 / 9562 (0.06%)	8 / 9531 (0.08%)
occurrences causally related to treatment / all	1 / 6	0 / 8
deaths causally related to treatment / all	1 / 6	0 / 8
Sudden death
subjects affected / exposed	5 / 9562 (0.05%)	5 / 9531 (0.05%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 5	0 / 5
Ulcer haemorrhage
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular stent occlusion
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular stent stenosis
subjects affected / exposed	6 / 9562 (0.06%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 6	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Immune system disorders
Allergy to arthropod bite
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anaphylactic reaction
subjects affected / exposed	0 / 9562 (0.00%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Anaphylactic shock
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Contrast media allergy
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Drug hypersensitivity
subjects affected / exposed	0 / 9562 (0.00%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 0	2 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Haemophagocytic lymphohistiocytosis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sarcoidosis
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Transplant rejection
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
Acquired hydrocele
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Acquired phimosis
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Benign prostatic hyperplasia
subjects affected / exposed	26 / 9562 (0.27%)	21 / 9531 (0.22%)
occurrences causally related to treatment / all	1 / 26	0 / 21
deaths causally related to treatment / all	0 / 0	0 / 0
Breast mass
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical dysplasia
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cervix disorder
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cystocele
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endometrial atrophy
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Endometrial hyperplasia
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Genital haemorrhage
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gynaecomastia
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian cyst
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Postmenopausal haemorrhage
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatic fibrosis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatic haemorrhage
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatic obstruction
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatism
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatitis
subjects affected / exposed	7 / 9562 (0.07%)	5 / 9531 (0.05%)
occurrences causally related to treatment / all	2 / 7	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatomegaly
subjects affected / exposed	3 / 9562 (0.03%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine fibrosis
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine haemorrhage
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine polyp
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine prolapse
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vaginal haemorrhage
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vaginal prolapse
subjects affected / exposed	3 / 9562 (0.03%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
subjects affected / exposed	6 / 9562 (0.06%)	7 / 9531 (0.07%)
occurrences causally related to treatment / all	0 / 8	0 / 7
deaths causally related to treatment / all	0 / 2	0 / 1
Acute respiratory distress syndrome
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Acute respiratory failure
subjects affected / exposed	11 / 9562 (0.12%)	7 / 9531 (0.07%)
occurrences causally related to treatment / all	0 / 12	0 / 7
deaths causally related to treatment / all	0 / 2	0 / 2
Aspiration
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Asthma
subjects affected / exposed	14 / 9562 (0.15%)	7 / 9531 (0.07%)
occurrences causally related to treatment / all	1 / 18	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Asthmatic crisis
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchial disorder
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchial obstruction
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchiectasis
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis chronic
subjects affected / exposed	3 / 9562 (0.03%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchospasm
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Choking
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic obstructive pulmonary disease
subjects affected / exposed	27 / 9562 (0.28%)	41 / 9531 (0.43%)
occurrences causally related to treatment / all	0 / 41	3 / 57
deaths causally related to treatment / all	0 / 0	0 / 1
Chronic respiratory failure
subjects affected / exposed	2 / 9562 (0.02%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Diaphragmatic paralysis
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspnoea
subjects affected / exposed	35 / 9562 (0.37%)	29 / 9531 (0.30%)
occurrences causally related to treatment / all	9 / 36	4 / 29
deaths causally related to treatment / all	0 / 0	0 / 1
Dyspnoea exertional
subjects affected / exposed	5 / 9562 (0.05%)	8 / 9531 (0.08%)
occurrences causally related to treatment / all	0 / 5	1 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Emphysema
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Epiglottic cyst
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Epistaxis
subjects affected / exposed	20 / 9562 (0.21%)	11 / 9531 (0.12%)
occurrences causally related to treatment / all	16 / 20	9 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Haemoptysis
subjects affected / exposed	4 / 9562 (0.04%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	2 / 4	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Haemothorax
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hydrothorax
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Idiopathic interstitial pneumonia
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Idiopathic pulmonary fibrosis
subjects affected / exposed	3 / 9562 (0.03%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Interstitial lung disease
subjects affected / exposed	3 / 9562 (0.03%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 6	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 1
Laryngeal oedema
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lung disorder
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Lung infiltration
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mediastinal haemorrhage
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nasal polyps
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nasal septum deviation
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Obstructive airways disorder
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Organising pneumonia
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Orthopnoea
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Paranasal cyst
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pleural effusion
subjects affected / exposed	1 / 9562 (0.01%)	5 / 9531 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Pleurisy
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia aspiration
subjects affected / exposed	3 / 9562 (0.03%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Pneumonitis
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumothorax
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumothorax spontaneous
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary arterial hypertension
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary congestion
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	16 / 9562 (0.17%)	19 / 9531 (0.20%)
occurrences causally related to treatment / all	0 / 16	1 / 19
deaths causally related to treatment / all	0 / 3	0 / 1
Pulmonary fibrosis
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary hypertension
subjects affected / exposed	0 / 9562 (0.00%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary mass
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary oedema
subjects affected / exposed	10 / 9562 (0.10%)	5 / 9531 (0.05%)
occurrences causally related to treatment / all	0 / 10	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 1
Pulmonary sarcoidosis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary toxicity
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory alkalosis
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory arrest
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory disorder
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory failure
subjects affected / exposed	8 / 9562 (0.08%)	8 / 9531 (0.08%)
occurrences causally related to treatment / all	0 / 9	0 / 8
deaths causally related to treatment / all	0 / 2	0 / 2
Restrictive pulmonary disease
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus congestion
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sleep apnoea syndrome
subjects affected / exposed	4 / 9562 (0.04%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Adjustment disorder
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Affective disorder
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anxiety
subjects affected / exposed	0 / 9562 (0.00%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Bipolar disorder
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Borderline personality disorder
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Completed suicide
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Confusional state
subjects affected / exposed	3 / 9562 (0.03%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	1 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Delirium
subjects affected / exposed	3 / 9562 (0.03%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Delirium tremens
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Depression
subjects affected / exposed	6 / 9562 (0.06%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 7	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Depression suicidal
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Disorientation
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Illness anxiety disorder
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Insomnia
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Major depression
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Mental disorder
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Mental status changes
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neuropsychiatric symptoms
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Suicide attempt
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Product issues
Device dislocation
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Device failure
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Device loosening
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Device malfunction
subjects affected / exposed	1 / 9562 (0.01%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Device occlusion
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
Alanine aminotransferase increased
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bile output decreased
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood follicle stimulating hormone increased
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood glucose fluctuation
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood glucose increased
subjects affected / exposed	5 / 9562 (0.05%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Blood lactic acid increased
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood potassium increased
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Blood pressure increased
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood urine present
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac stress test abnormal
subjects affected / exposed	3 / 9562 (0.03%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Electrocardiogram abnormal
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Glycosylated haemoglobin increased
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemoglobin decreased
subjects affected / exposed	2 / 9562 (0.02%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	1 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Heart rate irregular
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic enzyme increased
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Occult blood positive
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oxygen saturation decreased
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatic specific antigen increased
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Troponin increased
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Weight decreased
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
White blood cell count decreased
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Electrocardiogram QRS complex prolonged
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Electrocardiogram ST segment depression
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis B surface antigen positive
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Abdominal injury
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Accident at home
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acetabulum fracture
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Adrenal gland injury
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia postoperative
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anastomotic leak
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anastomotic stenosis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ankle fracture
subjects affected / exposed	8 / 9562 (0.08%)	8 / 9531 (0.08%)
occurrences causally related to treatment / all	0 / 8	1 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Arterial bypass thrombosis
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Arthropod bite
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Avulsion fracture
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Brain contusion
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Burns third degree
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Carbon monoxide poisoning
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery restenosis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cataract traumatic
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical vertebral fracture
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Clavicle fracture
subjects affected / exposed	1 / 9562 (0.01%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Concussion
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Contusion
subjects affected / exposed	7 / 9562 (0.07%)	7 / 9531 (0.07%)
occurrences causally related to treatment / all	0 / 7	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery restenosis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary vascular graft occlusion
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary vascular graft stenosis
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Craniocerebral injury
subjects affected / exposed	5 / 9562 (0.05%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Dislocation of sternum
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Epidural haemorrhage
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Extradural haematoma
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Extraskeletal ossification
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Facial bones fracture
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Failure to anastomose
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fall
subjects affected / exposed	5 / 9562 (0.05%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Femoral neck fracture
subjects affected / exposed	3 / 9562 (0.03%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Femur fracture
subjects affected / exposed	8 / 9562 (0.08%)	15 / 9531 (0.16%)
occurrences causally related to treatment / all	0 / 8	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Fibula fracture
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Foot fracture
subjects affected / exposed	2 / 9562 (0.02%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Foreign body
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Foreign body in gastrointestinal tract
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Fracture
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fractured sacrum
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hand fracture
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Head injury
subjects affected / exposed	8 / 9562 (0.08%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 8	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Heat stroke
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hip fracture
subjects affected / exposed	8 / 9562 (0.08%)	9 / 9531 (0.09%)
occurrences causally related to treatment / all	0 / 8	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Humerus fracture
subjects affected / exposed	12 / 9562 (0.13%)	8 / 9531 (0.08%)
occurrences causally related to treatment / all	0 / 12	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Hyphaema
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Incisional hernia
subjects affected / exposed	1 / 9562 (0.01%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc injury
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Joint dislocation
subjects affected / exposed	2 / 9562 (0.02%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Joint injury
subjects affected / exposed	3 / 9562 (0.03%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	1 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Ligament injury
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ligament rupture
subjects affected / exposed	4 / 9562 (0.04%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ligament sprain
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Limb injury
subjects affected / exposed	12 / 9562 (0.13%)	7 / 9531 (0.07%)
occurrences causally related to treatment / all	0 / 13	1 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Lower limb fracture
subjects affected / exposed	2 / 9562 (0.02%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar vertebral fracture
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbosacral plexus injury
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Median nerve injury
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Meniscus injury
subjects affected / exposed	9 / 9562 (0.09%)	5 / 9531 (0.05%)
occurrences causally related to treatment / all	0 / 9	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple fractures
subjects affected / exposed	3 / 9562 (0.03%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple injuries
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle injury
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle strain
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nail injury
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nerve injury
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nerve root injury
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nerve root injury lumbar
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Overdose
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Patella fracture
subjects affected / exposed	2 / 9562 (0.02%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic fracture
subjects affected / exposed	3 / 9562 (0.03%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Periorbital haemorrhage
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Periprocedural myocardial infarction
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Post procedural complication
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural fever
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural haematoma
subjects affected / exposed	4 / 9562 (0.04%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	1 / 4	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural haemorrhage
subjects affected / exposed	11 / 9562 (0.12%)	5 / 9531 (0.05%)
occurrences causally related to treatment / all	6 / 11	4 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative ileus
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative respiratory failure
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative thoracic procedure complication
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural complication
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural haemorrhage
subjects affected / exposed	2 / 9562 (0.02%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	1 / 2	2 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural pain
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pubis fracture
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary contusion
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Radiation pneumonitis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Radius fracture
subjects affected / exposed	6 / 9562 (0.06%)	8 / 9531 (0.08%)
occurrences causally related to treatment / all	0 / 7	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Rib fracture
subjects affected / exposed	4 / 9562 (0.04%)	10 / 9531 (0.10%)
occurrences causally related to treatment / all	0 / 4	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Road traffic accident
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Scapula fracture
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Seroma
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Shunt malfunction
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skeletal injury
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin abrasion
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin injury
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin laceration
subjects affected / exposed	2 / 9562 (0.02%)	6 / 9531 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Skull fracture
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skull fractured base
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal column injury
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal compression fracture
subjects affected / exposed	0 / 9562 (0.00%)	7 / 9531 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal cord injury cervical
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal fracture
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sternal fracture
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Stomal hernia
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subcutaneous haematoma
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Subdural haematoma
subjects affected / exposed	23 / 9562 (0.24%)	6 / 9531 (0.06%)
occurrences causally related to treatment / all	12 / 23	3 / 6
deaths causally related to treatment / all	0 / 2	0 / 0
Subdural haemorrhage
subjects affected / exposed	8 / 9562 (0.08%)	5 / 9531 (0.05%)
occurrences causally related to treatment / all	3 / 8	3 / 5
deaths causally related to treatment / all	0 / 0	2 / 2
Tendon injury
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tendon rupture
subjects affected / exposed	2 / 9562 (0.02%)	8 / 9531 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Thermal burn
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Thoracic vertebral fracture
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Tibia fracture
subjects affected / exposed	3 / 9562 (0.03%)	6 / 9531 (0.06%)
occurrences causally related to treatment / all	0 / 3	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Toxicity to various agents
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic fracture
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic haematoma
subjects affected / exposed	7 / 9562 (0.07%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	4 / 7	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic haemorrhage
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Traumatic haemothorax
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic intracranial haemorrhage
subjects affected / exposed	11 / 9562 (0.12%)	7 / 9531 (0.07%)
occurrences causally related to treatment / all	4 / 11	1 / 7
deaths causally related to treatment / all	1 / 2	0 / 0
Ulna fracture
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Upper limb fracture
subjects affected / exposed	6 / 9562 (0.06%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 6	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary retention postoperative
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular graft complication
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular graft thrombosis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular pseudoaneurysm
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wound
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wound dehiscence
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wound haemorrhage
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wound necrosis
subjects affected / exposed	0 / 9562 (0.00%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Wrist fracture
subjects affected / exposed	2 / 9562 (0.02%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Congenital, familial and genetic disorders
Corneal dystrophy
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Glucose-6-phosphate dehydrogenase deficiency
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neurofibromatosis
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Acute coronary syndrome
subjects affected / exposed	20 / 9562 (0.21%)	22 / 9531 (0.23%)
occurrences causally related to treatment / all	3 / 20	1 / 22
deaths causally related to treatment / all	0 / 1	0 / 2
Acute left ventricular failure
subjects affected / exposed	5 / 9562 (0.05%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 6	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Acute myocardial infarction
subjects affected / exposed	126 / 9562 (1.32%)	197 / 9531 (2.07%)
occurrences causally related to treatment / all	6 / 133	7 / 203
deaths causally related to treatment / all	0 / 14	0 / 19
Angina pectoris
subjects affected / exposed	200 / 9562 (2.09%)	251 / 9531 (2.63%)
occurrences causally related to treatment / all	5 / 239	7 / 267
deaths causally related to treatment / all	0 / 0	0 / 0
Angina unstable
subjects affected / exposed	354 / 9562 (3.70%)	405 / 9531 (4.25%)
occurrences causally related to treatment / all	13 / 403	16 / 449
deaths causally related to treatment / all	0 / 0	1 / 1
Aortic valve disease
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve incompetence
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve stenosis
subjects affected / exposed	8 / 9562 (0.08%)	14 / 9531 (0.15%)
occurrences causally related to treatment / all	0 / 8	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Arrhythmia
subjects affected / exposed	0 / 9562 (0.00%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 1
Arteriosclerosis coronary artery
subjects affected / exposed	9 / 9562 (0.09%)	8 / 9531 (0.08%)
occurrences causally related to treatment / all	0 / 9	0 / 8
deaths causally related to treatment / all	0 / 1	0 / 1
Atrial fibrillation
subjects affected / exposed	82 / 9562 (0.86%)	76 / 9531 (0.80%)
occurrences causally related to treatment / all	0 / 84	3 / 80
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial flutter
subjects affected / exposed	12 / 9562 (0.13%)	13 / 9531 (0.14%)
occurrences causally related to treatment / all	0 / 13	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial tachycardia
subjects affected / exposed	2 / 9562 (0.02%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial thrombosis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block
subjects affected / exposed	2 / 9562 (0.02%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block complete
subjects affected / exposed	16 / 9562 (0.17%)	18 / 9531 (0.19%)
occurrences causally related to treatment / all	3 / 16	2 / 18
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block first degree
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block second degree
subjects affected / exposed	12 / 9562 (0.13%)	6 / 9531 (0.06%)
occurrences causally related to treatment / all	1 / 12	1 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Bifascicular block
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bradyarrhythmia
subjects affected / exposed	2 / 9562 (0.02%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bradycardia
subjects affected / exposed	15 / 9562 (0.16%)	6 / 9531 (0.06%)
occurrences causally related to treatment / all	2 / 15	1 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Bundle branch block left
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bundle branch block right
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac arrest
subjects affected / exposed	7 / 9562 (0.07%)	12 / 9531 (0.13%)
occurrences causally related to treatment / all	1 / 7	1 / 12
deaths causally related to treatment / all	1 / 6	1 / 9
Cardiac disorder
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure
subjects affected / exposed	64 / 9562 (0.67%)	87 / 9531 (0.91%)
occurrences causally related to treatment / all	2 / 84	0 / 108
deaths causally related to treatment / all	0 / 11	0 / 9
Cardiac failure acute
subjects affected / exposed	20 / 9562 (0.21%)	14 / 9531 (0.15%)
occurrences causally related to treatment / all	6 / 27	0 / 15
deaths causally related to treatment / all	0 / 4	0 / 4
Cardiac failure chronic
subjects affected / exposed	18 / 9562 (0.19%)	30 / 9531 (0.31%)
occurrences causally related to treatment / all	0 / 19	1 / 44
deaths causally related to treatment / all	0 / 1	1 / 2
Cardiac failure congestive
subjects affected / exposed	60 / 9562 (0.63%)	47 / 9531 (0.49%)
occurrences causally related to treatment / all	0 / 71	2 / 53
deaths causally related to treatment / all	0 / 4	0 / 3
Cardiac tamponade
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
Cardiac valve disease
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac ventricular scarring
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardio-respiratory arrest
subjects affected / exposed	3 / 9562 (0.03%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 2	0 / 2
Cardiogenic shock
subjects affected / exposed	6 / 9562 (0.06%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 6	0 / 4
deaths causally related to treatment / all	0 / 4	0 / 4
Cardiomyopathy
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiopulmonary failure
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 1
Cardiovascular insufficiency
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Coronary artery disease
subjects affected / exposed	85 / 9562 (0.89%)	90 / 9531 (0.94%)
occurrences causally related to treatment / all	3 / 89	5 / 95
deaths causally related to treatment / all	0 / 0	0 / 2
Coronary artery insufficiency
subjects affected / exposed	2 / 9562 (0.02%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 1
Coronary artery occlusion
subjects affected / exposed	2 / 9562 (0.02%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery stenosis
subjects affected / exposed	14 / 9562 (0.15%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 14	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Dressler's syndrome
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Extrasystoles
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive heart disease
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic cardiomyopathy
subjects affected / exposed	3 / 9562 (0.03%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 3	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Left ventricular dysfunction
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Left ventricular failure
subjects affected / exposed	7 / 9562 (0.07%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 8	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 0
Microvascular coronary artery disease
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mitral valve incompetence
subjects affected / exposed	2 / 9562 (0.02%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Mitral valve stenosis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial fibrosis
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Myocardial infarction
subjects affected / exposed	41 / 9562 (0.43%)	65 / 9531 (0.68%)
occurrences causally related to treatment / all	0 / 43	1 / 66
deaths causally related to treatment / all	0 / 11	0 / 16
Myocardial ischaemia
subjects affected / exposed	36 / 9562 (0.38%)	47 / 9531 (0.49%)
occurrences causally related to treatment / all	1 / 37	0 / 50
deaths causally related to treatment / all	0 / 0	0 / 2
Myocarditis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nodal arrhythmia
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Palpitations
subjects affected / exposed	4 / 9562 (0.04%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pericardial effusion
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pericardial haemorrhage
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pericarditis
subjects affected / exposed	3 / 9562 (0.03%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pericarditis constrictive
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prinzmetal angina
subjects affected / exposed	0 / 9562 (0.00%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary valve incompetence
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Right ventricular failure
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Sinoatrial block
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus arrhythmia
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus bradycardia
subjects affected / exposed	7 / 9562 (0.07%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 7	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus node dysfunction
subjects affected / exposed	5 / 9562 (0.05%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	1 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus tachycardia
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Stress cardiomyopathy
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Supraventricular extrasystoles
subjects affected / exposed	3 / 9562 (0.03%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Supraventricular tachycardia
subjects affected / exposed	5 / 9562 (0.05%)	9 / 9531 (0.09%)
occurrences causally related to treatment / all	1 / 5	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Tachycardia
subjects affected / exposed	1 / 9562 (0.01%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Tricuspid valve incompetence
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular arrhythmia
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular asystole
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0
Ventricular extrasystoles
subjects affected / exposed	4 / 9562 (0.04%)	7 / 9531 (0.07%)
occurrences causally related to treatment / all	0 / 4	1 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular fibrillation
subjects affected / exposed	2 / 9562 (0.02%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 0
Ventricular tachycardia
subjects affected / exposed	10 / 9562 (0.10%)	6 / 9531 (0.06%)
occurrences causally related to treatment / all	1 / 10	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Adams-Stokes syndrome
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Ageusia
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Altered state of consciousness
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Amnesia
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ataxia
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Balance disorder
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Basal ganglia haemorrhage
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Basal ganglia infarction
subjects affected / exposed	0 / 9562 (0.00%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Brain hypoxia
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Brain injury
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Brain stem haemorrhage
subjects affected / exposed	3 / 9562 (0.03%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	2 / 3	0 / 0
deaths causally related to treatment / all	2 / 3	0 / 0
Brain stem infarction
subjects affected / exposed	1 / 9562 (0.01%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Brain stem stroke
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid arteriosclerosis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery disease
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery occlusion
subjects affected / exposed	3 / 9562 (0.03%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery stenosis
subjects affected / exposed	18 / 9562 (0.19%)	21 / 9531 (0.22%)
occurrences causally related to treatment / all	0 / 18	0 / 22
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid sinus syndrome
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Carpal tunnel syndrome
subjects affected / exposed	3 / 9562 (0.03%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cauda equina syndrome
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebellar haemorrhage
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebellar infarction
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebellar stroke
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral arteriosclerosis
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral atrophy
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral haematoma
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral haemorrhage
subjects affected / exposed	6 / 9562 (0.06%)	6 / 9531 (0.06%)
occurrences causally related to treatment / all	3 / 6	3 / 6
deaths causally related to treatment / all	1 / 2	2 / 4
Cerebral infarction
subjects affected / exposed	18 / 9562 (0.19%)	27 / 9531 (0.28%)
occurrences causally related to treatment / all	2 / 19	2 / 28
deaths causally related to treatment / all	0 / 2	0 / 3
Cerebral ischaemia
subjects affected / exposed	7 / 9562 (0.07%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 9	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral small vessel ischaemic disease
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebrovascular accident
subjects affected / exposed	3 / 9562 (0.03%)	9 / 9531 (0.09%)
occurrences causally related to treatment / all	0 / 3	1 / 9
deaths causally related to treatment / all	0 / 1	0 / 1
Cerebrovascular insufficiency
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical cord compression
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical radiculopathy
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cervicobrachial syndrome
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cluster headache
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cognitive disorder
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Coma
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
Dementia
subjects affected / exposed	2 / 9562 (0.02%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
Diabetic coma
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic neuropathy
subjects affected / exposed	9 / 9562 (0.09%)	13 / 9531 (0.14%)
occurrences causally related to treatment / all	0 / 10	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Dizziness
subjects affected / exposed	14 / 9562 (0.15%)	12 / 9531 (0.13%)
occurrences causally related to treatment / all	1 / 15	2 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Dysarthria
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Embolic cerebral infarction
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Embolic stroke
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Encephalopathy
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Epilepsy
subjects affected / exposed	1 / 9562 (0.01%)	5 / 9531 (0.05%)
occurrences causally related to treatment / all	0 / 2	1 / 7
deaths causally related to treatment / all	0 / 0	0 / 1
Epileptic encephalopathy
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Essential tremor
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Facial paralysis
subjects affected / exposed	1 / 9562 (0.01%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 1	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Focal dyscognitive seizures
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Generalised tonic-clonic seizure
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhage intracranial
subjects affected / exposed	1 / 9562 (0.01%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	1 / 1	2 / 4
deaths causally related to treatment / all	1 / 1	0 / 1
Haemorrhagic stroke
subjects affected / exposed	10 / 9562 (0.10%)	9 / 9531 (0.09%)
occurrences causally related to treatment / all	7 / 10	6 / 9
deaths causally related to treatment / all	3 / 3	1 / 2
Haemorrhagic transformation stroke
subjects affected / exposed	0 / 9562 (0.00%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Headache
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hemianopia
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hemiparesis
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic encephalopathy
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hydrocephalus
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive encephalopathy
subjects affected / exposed	5 / 9562 (0.05%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoaesthesia
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoglycaemic coma
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoglycaemic encephalopathy
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoglycaemic seizure
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoglycaemic unconsciousness
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intracranial aneurysm
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intracranial pressure increased
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic cerebral infarction
subjects affected / exposed	0 / 9562 (0.00%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 0	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic stroke
subjects affected / exposed	85 / 9562 (0.89%)	119 / 9531 (1.25%)
occurrences causally related to treatment / all	1 / 88	0 / 127
deaths causally related to treatment / all	0 / 8	0 / 5
Lacunar infarction
subjects affected / exposed	9 / 9562 (0.09%)	5 / 9531 (0.05%)
occurrences causally related to treatment / all	0 / 10	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Lacunar stroke
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Loss of consciousness
subjects affected / exposed	4 / 9562 (0.04%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 4	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar radiculopathy
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbosacral radiculopathy
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolic encephalopathy
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Microsleep
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Migraine
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myasthenia gravis
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Myelopathy
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nerve compression
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neuropathy peripheral
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Normal pressure hydrocephalus
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Paraesthesia
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Paralysis
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Parkinson's disease
subjects affected / exposed	1 / 9562 (0.01%)	7 / 9531 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Parkinsonism
subjects affected / exposed	0 / 9562 (0.00%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral nerve lesion
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Petit mal epilepsy
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Polyneuropathy
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post-traumatic headache
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Presyncope
subjects affected / exposed	5 / 9562 (0.05%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Pseudoradicular syndrome
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Putamen haemorrhage
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Radicular pain
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Radiculopathy
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Sciatica
subjects affected / exposed	4 / 9562 (0.04%)	9 / 9531 (0.09%)
occurrences causally related to treatment / all	0 / 4	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Sedation
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Seizure
subjects affected / exposed	2 / 9562 (0.02%)	6 / 9531 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal cord compression
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal epidural haematoma
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subarachnoid haemorrhage
subjects affected / exposed	2 / 9562 (0.02%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	1 / 2	3 / 3
deaths causally related to treatment / all	0 / 0	1 / 1
Syncope
subjects affected / exposed	26 / 9562 (0.27%)	27 / 9531 (0.28%)
occurrences causally related to treatment / all	0 / 29	1 / 28
deaths causally related to treatment / all	0 / 0	0 / 0
Tension headache
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thalamic infarction
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thalamus haemorrhage
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thoracic outlet syndrome
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Toxic encephalopathy
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Transient global amnesia
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Transient ischaemic attack
subjects affected / exposed	39 / 9562 (0.41%)	33 / 9531 (0.35%)
occurrences causally related to treatment / all	3 / 39	1 / 34
deaths causally related to treatment / all	0 / 0	0 / 0
Tremor
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular dementia
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Vascular encephalopathy
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vertebral artery dissection
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vertebral artery stenosis
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vertebrobasilar insufficiency
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dementia with Lewy bodies
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
IIIrd nerve paralysis
subjects affected / exposed	0 / 9562 (0.00%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Miller Fisher syndrome
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
VIth nerve disorder
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
VIth nerve paralysis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
VIth nerve paresis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vertigo CNS origin
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Abdominal lymphadenopathy
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Agranulocytosis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia
subjects affected / exposed	20 / 9562 (0.21%)	14 / 9531 (0.15%)
occurrences causally related to treatment / all	13 / 20	3 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia macrocytic
subjects affected / exposed	3 / 9562 (0.03%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	1 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia of chronic disease
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	1 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia of malignant disease
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	1 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Deficiency anaemia
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Disseminated intravascular coagulation
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic anaemia
subjects affected / exposed	10 / 9562 (0.10%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	7 / 10	2 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hypochromic anaemia
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Immune thrombocytopenic purpura
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Increased tendency to bruise
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Iron deficiency anaemia
subjects affected / exposed	26 / 9562 (0.27%)	6 / 9531 (0.06%)
occurrences causally related to treatment / all	13 / 26	1 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Leukocytosis
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphadenopathy
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Microcytic anaemia
subjects affected / exposed	3 / 9562 (0.03%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	1 / 3	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nephrogenic anaemia
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neutropenia
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Normochromic normocytic anaemia
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Normocytic anaemia
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	1 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancytopenia
subjects affected / exposed	3 / 9562 (0.03%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	1 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Splenic infarction
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spontaneous haematoma
subjects affected / exposed	3 / 9562 (0.03%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	3 / 3	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Spontaneous haemorrhage
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombocytopenia
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia vitamin B12 deficiency
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ear and labyrinth disorders
Deafness
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Deafness neurosensory
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Deafness unilateral
subjects affected / exposed	3 / 9562 (0.03%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ear pain
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Eustachian tube dysfunction
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoacusis
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Inner ear disorder
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Meniere's disease
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sudden hearing loss
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tinnitus
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tympanic membrane perforation
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tympanosclerosis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vertigo
subjects affected / exposed	13 / 9562 (0.14%)	7 / 9531 (0.07%)
occurrences causally related to treatment / all	0 / 13	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Vertigo positional
subjects affected / exposed	7 / 9562 (0.07%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 7	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Vestibular disorder
subjects affected / exposed	2 / 9562 (0.02%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 2	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
Age-related macular degeneration
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Aphakia
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cataract
subjects affected / exposed	22 / 9562 (0.23%)	30 / 9531 (0.31%)
occurrences causally related to treatment / all	0 / 26	1 / 35
deaths causally related to treatment / all	0 / 0	0 / 0
Cataract cortical
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cataract diabetic
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cataract nuclear
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Corneal degeneration
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic retinopathy
subjects affected / exposed	3 / 9562 (0.03%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Entropion
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Eye haemorrhage
subjects affected / exposed	4 / 9562 (0.04%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	3 / 4	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Eyelid ptosis
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Glaucoma
subjects affected / exposed	2 / 9562 (0.02%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Lacrimal disorder
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Macular degeneration
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Macular fibrosis
subjects affected / exposed	2 / 9562 (0.02%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Macular oedema
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Macular pseudohole
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Maculopathy
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Open angle glaucoma
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Optic ischaemic neuropathy
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal artery occlusion
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal artery thrombosis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal degeneration
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal detachment
subjects affected / exposed	2 / 9562 (0.02%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal haemorrhage
subjects affected / exposed	2 / 9562 (0.02%)	5 / 9531 (0.05%)
occurrences causally related to treatment / all	2 / 2	3 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal vein occlusion
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal vein thrombosis
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retinopathy
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retinopathy proliferative
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rhegmatogenous retinal detachment
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Strabismus
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Trichiasis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ulcerative keratitis
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Visual impairment
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vitreous haemorrhage
subjects affected / exposed	9 / 9562 (0.09%)	5 / 9531 (0.05%)
occurrences causally related to treatment / all	5 / 9	2 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Vitreous opacities
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal discomfort
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal distension
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal hernia
subjects affected / exposed	2 / 9562 (0.02%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain
subjects affected / exposed	7 / 9562 (0.07%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 7	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain lower
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain upper
subjects affected / exposed	1 / 9562 (0.01%)	5 / 9531 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal wall haematoma
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anal fissure
subjects affected / exposed	0 / 9562 (0.00%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Anal fistula
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anal haemorrhage
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anal inflammation
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis noninfective
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Appendix disorder
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ascites
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Barrett's oesophagus
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bezoar
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Change of bowel habit
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic gastritis
subjects affected / exposed	2 / 9562 (0.02%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic gastrointestinal bleeding
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Coeliac disease
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis
subjects affected / exposed	4 / 9562 (0.04%)	5 / 9531 (0.05%)
occurrences causally related to treatment / all	0 / 4	1 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis ischaemic
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Constipation
subjects affected / exposed	4 / 9562 (0.04%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Dental caries
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic gastroparesis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Diaphragmatic hernia
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	18 / 9562 (0.19%)	8 / 9531 (0.08%)
occurrences causally related to treatment / all	1 / 18	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticular perforation
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Diverticulitis oesophageal
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulum
subjects affected / exposed	3 / 9562 (0.03%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 3	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulum intestinal
subjects affected / exposed	4 / 9562 (0.04%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	1 / 4	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulum intestinal haemorrhagic
subjects affected / exposed	5 / 9562 (0.05%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	4 / 6	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal polyp
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer
subjects affected / exposed	4 / 9562 (0.04%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	2 / 4	2 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer haemorrhage
subjects affected / exposed	7 / 9562 (0.07%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	7 / 8	4 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenitis
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspepsia
subjects affected / exposed	3 / 9562 (0.03%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dysphagia
subjects affected / exposed	2 / 9562 (0.02%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Enteritis
subjects affected / exposed	2 / 9562 (0.02%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Enterocolitis
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Epigastric discomfort
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Erosive oesophagitis
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Faecaloma
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Faeces discoloured
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Food poisoning
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Functional gastrointestinal disorder
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric antral vascular ectasia
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric disorder
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric haemorrhage
subjects affected / exposed	6 / 9562 (0.06%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	5 / 6	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric polyps
subjects affected / exposed	5 / 9562 (0.05%)	6 / 9531 (0.06%)
occurrences causally related to treatment / all	0 / 5	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric ulcer
subjects affected / exposed	18 / 9562 (0.19%)	9 / 9531 (0.09%)
occurrences causally related to treatment / all	8 / 18	1 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric ulcer haemorrhage
subjects affected / exposed	6 / 9562 (0.06%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	2 / 6	3 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric ulcer perforation
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis
subjects affected / exposed	8 / 9562 (0.08%)	12 / 9531 (0.13%)
occurrences causally related to treatment / all	2 / 8	2 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis erosive
subjects affected / exposed	9 / 9562 (0.09%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	4 / 9	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis haemorrhagic
subjects affected / exposed	6 / 9562 (0.06%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	3 / 6	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroduodenal ulcer
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal angiodysplasia
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	2 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorder
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	1 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal haemorrhage
subjects affected / exposed	43 / 9562 (0.45%)	22 / 9531 (0.23%)
occurrences causally related to treatment / all	30 / 44	18 / 23
deaths causally related to treatment / all	0 / 1	0 / 0
Gastrointestinal inflammation
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal ischaemia
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal motility disorder
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal polyp haemorrhage
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	2 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal stenosis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal ulcer haemorrhage
subjects affected / exposed	3 / 9562 (0.03%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	2 / 3	2 / 2
deaths causally related to treatment / all	1 / 1	0 / 0
Gastrooesophageal reflux disease
subjects affected / exposed	5 / 9562 (0.05%)	7 / 9531 (0.07%)
occurrences causally related to treatment / all	0 / 6	2 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Haematemesis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haematochezia
subjects affected / exposed	4 / 9562 (0.04%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	3 / 4	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic erosive gastritis
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	1 / 1	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhoidal haemorrhage
subjects affected / exposed	3 / 9562 (0.03%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	2 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhoids
subjects affected / exposed	5 / 9562 (0.05%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 5	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hernial eventration
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hiatus hernia
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ileus
subjects affected / exposed	4 / 9562 (0.04%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Ileus paralytic
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Incarcerated inguinal hernia
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Inguinal hernia
subjects affected / exposed	16 / 9562 (0.17%)	20 / 9531 (0.21%)
occurrences causally related to treatment / all	0 / 16	0 / 20
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal haemorrhage
subjects affected / exposed	6 / 9562 (0.06%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	4 / 6	2 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal ischaemia
subjects affected / exposed	0 / 9562 (0.00%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 2
Intestinal obstruction
subjects affected / exposed	4 / 9562 (0.04%)	5 / 9531 (0.05%)
occurrences causally related to treatment / all	0 / 6	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal perforation
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal polyp
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal pseudo-obstruction
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal strangulation
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestinal haemorrhage
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine perforation
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine polyp
subjects affected / exposed	18 / 9562 (0.19%)	14 / 9531 (0.15%)
occurrences causally related to treatment / all	1 / 18	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Lower gastrointestinal haemorrhage
subjects affected / exposed	3 / 9562 (0.03%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	3 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar hernia
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Mechanical ileus
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Melaena
subjects affected / exposed	12 / 9562 (0.13%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	5 / 12	3 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Nausea
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Obstruction gastric
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Obstructive pancreatitis
subjects affected / exposed	2 / 9562 (0.02%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal motility disorder
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal spasm
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal ulcer
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal ulcer haemorrhage
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophagitis
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophagitis ulcerative
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic mass
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic pseudocyst
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis
subjects affected / exposed	11 / 9562 (0.12%)	7 / 9531 (0.07%)
occurrences causally related to treatment / all	0 / 14	0 / 7
deaths causally related to treatment / all	0 / 2	0 / 1
Pancreatitis acute
subjects affected / exposed	2 / 9562 (0.02%)	5 / 9531 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis chronic
subjects affected / exposed	4 / 9562 (0.04%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatolithiasis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peptic ulcer
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peptic ulcer haemorrhage
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Periodontal disease
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peritoneal adhesions
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peritoneal haemorrhage
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Proctitis
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal haemorrhage
subjects affected / exposed	13 / 9562 (0.14%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	11 / 13	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal polyp
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal prolapse
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Reflux gastritis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Salivary gland calculus
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestinal haemorrhage
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestinal obstruction
subjects affected / exposed	3 / 9562 (0.03%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Subileus
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Swollen tongue
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Tooth disorder
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tooth socket haemorrhage
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ulcerative gastritis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Umbilical hernia
subjects affected / exposed	4 / 9562 (0.04%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Umbilical hernia, obstructive
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Upper gastrointestinal haemorrhage
subjects affected / exposed	22 / 9562 (0.23%)	10 / 9531 (0.10%)
occurrences causally related to treatment / all	17 / 23	7 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Varices oesophageal
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vomiting
subjects affected / exposed	2 / 9562 (0.02%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Mallory-Weiss syndrome
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	2 / 2	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Acute hepatic failure
subjects affected / exposed	3 / 9562 (0.03%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bile duct obstruction
subjects affected / exposed	2 / 9562 (0.02%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Bile duct stone
subjects affected / exposed	7 / 9562 (0.07%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 7	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary colic
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary dyskinesia
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cholangitis
subjects affected / exposed	1 / 9562 (0.01%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 1
Cholangitis acute
subjects affected / exposed	3 / 9562 (0.03%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cholangitis chronic
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis
subjects affected / exposed	13 / 9562 (0.14%)	23 / 9531 (0.24%)
occurrences causally related to treatment / all	0 / 14	0 / 27
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis acute
subjects affected / exposed	19 / 9562 (0.20%)	14 / 9531 (0.15%)
occurrences causally related to treatment / all	0 / 19	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis chronic
subjects affected / exposed	5 / 9562 (0.05%)	6 / 9531 (0.06%)
occurrences causally related to treatment / all	0 / 5	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 1
Cholelithiasis
subjects affected / exposed	23 / 9562 (0.24%)	25 / 9531 (0.26%)
occurrences causally related to treatment / all	0 / 24	0 / 25
deaths causally related to treatment / all	0 / 0	0 / 0
Cholestasis
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic hepatitis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cirrhosis alcoholic
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Drug-induced liver injury
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gallbladder disorder
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic cirrhosis
subjects affected / exposed	4 / 9562 (0.04%)	7 / 9531 (0.07%)
occurrences causally related to treatment / all	1 / 4	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 1
Hepatic failure
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic function abnormal
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis acute
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Jaundice
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Jaundice cholestatic
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Liver injury
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Non-alcoholic steatohepatitis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Portal vein thrombosis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Steatohepatitis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Actinic elastosis
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Angioedema
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Decubitus ulcer
subjects affected / exposed	0 / 9562 (0.00%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Dermal cyst
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dermatitis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic foot
subjects affected / exposed	29 / 9562 (0.30%)	18 / 9531 (0.19%)
occurrences causally related to treatment / all	0 / 32	0 / 25
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic ulcer
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ecchymosis
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eczema
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intertrigo
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic skin ulcer
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Lichen planus
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myxoid cyst
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Necrobiosis lipoidica diabeticorum
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Petechiae
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prurigo
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Psoriasis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rash
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin exfoliation
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin mass
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin necrosis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin ulcer
subjects affected / exposed	7 / 9562 (0.07%)	12 / 9531 (0.13%)
occurrences causally related to treatment / all	0 / 7	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Toxic skin eruption
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urticaria
subjects affected / exposed	3 / 9562 (0.03%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	1 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Henoch-Schonlein purpura
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Stevens-Johnson syndrome
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	56 / 9562 (0.59%)	39 / 9531 (0.41%)
occurrences causally related to treatment / all	2 / 59	2 / 43
deaths causally related to treatment / all	0 / 1	0 / 1
Azotaemia
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder neck obstruction
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder neck sclerosis
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder outlet obstruction
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder tamponade
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Calculus bladder
subjects affected / exposed	3 / 9562 (0.03%)	7 / 9531 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Calculus urethral
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Calculus urinary
subjects affected / exposed	6 / 9562 (0.06%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	1 / 7	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic kidney disease
subjects affected / exposed	9 / 9562 (0.09%)	15 / 9531 (0.16%)
occurrences causally related to treatment / all	0 / 10	0 / 15
deaths causally related to treatment / all	0 / 1	0 / 0
Cystitis haemorrhagic
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic nephropathy
subjects affected / exposed	6 / 9562 (0.06%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 6	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Dysuria
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
End stage renal disease
subjects affected / exposed	4 / 9562 (0.04%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 0
Glomerulonephritis
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Glomerulosclerosis
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haematuria
subjects affected / exposed	32 / 9562 (0.33%)	13 / 9531 (0.14%)
occurrences causally related to treatment / all	16 / 33	8 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhage urinary tract
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hydronephrosis
subjects affected / exposed	4 / 9562 (0.04%)	7 / 9531 (0.07%)
occurrences causally related to treatment / all	0 / 4	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive nephropathy
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Micturition disorder
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nephritic syndrome
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nephrolithiasis
subjects affected / exposed	16 / 9562 (0.17%)	21 / 9531 (0.22%)
occurrences causally related to treatment / all	1 / 19	1 / 24
deaths causally related to treatment / all	0 / 0	0 / 0
Nephropathy toxic
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nephrotic syndrome
subjects affected / exposed	1 / 9562 (0.01%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvi-ureteric obstruction
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Perinephritis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Proteinuria
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal artery arteriosclerosis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Renal artery occlusion
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal artery stenosis
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Renal colic
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cyst
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal disorder
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal failure
subjects affected / exposed	16 / 9562 (0.17%)	15 / 9531 (0.16%)
occurrences causally related to treatment / all	2 / 17	2 / 15
deaths causally related to treatment / all	0 / 0	0 / 1
Renal haemorrhage
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal hypertension
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal impairment
subjects affected / exposed	10 / 9562 (0.10%)	8 / 9531 (0.08%)
occurrences causally related to treatment / all	0 / 10	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Renal injury
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal mass
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Stress urinary incontinence
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tubulointerstitial nephritis
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ureteric stenosis
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ureterolithiasis
subjects affected / exposed	18 / 9562 (0.19%)	13 / 9531 (0.14%)
occurrences causally related to treatment / all	1 / 20	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Urethral haemorrhage
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urethral stenosis
subjects affected / exposed	5 / 9562 (0.05%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary bladder polyp
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary incontinence
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary retention
subjects affected / exposed	4 / 9562 (0.04%)	7 / 9531 (0.07%)
occurrences causally related to treatment / all	0 / 4	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract obstruction
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Endocrine disorders
Adrenal insufficiency
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Goitre
subjects affected / exposed	5 / 9562 (0.05%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 6	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperparathyroidism
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperparathyroidism primary
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperthyroidism
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypothyroidism
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thyroiditis subacute
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	5 / 9562 (0.05%)	6 / 9531 (0.06%)
occurrences causally related to treatment / all	0 / 5	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis
subjects affected / exposed	4 / 9562 (0.04%)	5 / 9531 (0.05%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis reactive
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arthropathy
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Back pain
subjects affected / exposed	10 / 9562 (0.10%)	14 / 9531 (0.15%)
occurrences causally related to treatment / all	0 / 11	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Bone pain
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bursitis
subjects affected / exposed	0 / 9562 (0.00%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical spinal stenosis
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chest wall mass
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chondromalacia
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Compartment syndrome
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Costochondritis
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Crystal arthropathy
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic amyotrophy
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dupuytren's contracture
subjects affected / exposed	0 / 9562 (0.00%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Facial asymmetry
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fistula
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Flank pain
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Foot deformity
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gouty arthritis
subjects affected / exposed	4 / 9562 (0.04%)	5 / 9531 (0.05%)
occurrences causally related to treatment / all	1 / 4	2 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Gouty tophus
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Inguinal mass
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc degeneration
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc disorder
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc protrusion
subjects affected / exposed	16 / 9562 (0.17%)	19 / 9531 (0.20%)
occurrences causally related to treatment / all	0 / 17	0 / 20
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc space narrowing
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Joint contracture
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Joint swelling
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Loose body in joint
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar spinal stenosis
subjects affected / exposed	13 / 9562 (0.14%)	7 / 9531 (0.07%)
occurrences causally related to treatment / all	0 / 13	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Meniscal degeneration
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle disorder
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Muscular weakness
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal chest pain
subjects affected / exposed	9 / 9562 (0.09%)	15 / 9531 (0.16%)
occurrences causally related to treatment / all	0 / 9	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal pain
subjects affected / exposed	2 / 9562 (0.02%)	9 / 9531 (0.09%)
occurrences causally related to treatment / all	0 / 2	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Myalgia
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Myofascitis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myopathy
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Myositis
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Neck pain
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neuropathic arthropathy
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoarthritis
subjects affected / exposed	47 / 9562 (0.49%)	55 / 9531 (0.58%)
occurrences causally related to treatment / all	1 / 51	1 / 57
deaths causally related to treatment / all	0 / 0	0 / 0
Osteochondrosis
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Osteonecrosis
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteopenia
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoporosis
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoporotic fracture
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteorrhagia
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pain in extremity
subjects affected / exposed	4 / 9562 (0.04%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	1 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Patellofemoral pain syndrome
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pathological fracture
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Periarthritis
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Polymyalgia rheumatica
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pseudarthrosis
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Psoriatic arthropathy
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rhabdomyolysis
subjects affected / exposed	6 / 9562 (0.06%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 6	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Rheumatoid arthritis
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rotator cuff syndrome
subjects affected / exposed	5 / 9562 (0.05%)	8 / 9531 (0.08%)
occurrences causally related to treatment / all	0 / 5	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Sacroiliitis
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Scoliosis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Seronegative arthritis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sjogren's syndrome
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Soft tissue disorder
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal column stenosis
subjects affected / exposed	8 / 9562 (0.08%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 8	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal ligament ossification
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal osteoarthritis
subjects affected / exposed	6 / 9562 (0.06%)	11 / 9531 (0.12%)
occurrences causally related to treatment / all	0 / 6	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal pain
subjects affected / exposed	5 / 9562 (0.05%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spondylitis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spondylolisthesis
subjects affected / exposed	2 / 9562 (0.02%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Synovial cyst
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tendon disorder
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tenosynovitis stenosans
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Abdominal abscess
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal sepsis
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal wall abscess
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abscess jaw
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abscess limb
subjects affected / exposed	5 / 9562 (0.05%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abscess neck
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acinetobacter infection
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Acute endocarditis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Acute sinusitis
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anal abscess
subjects affected / exposed	3 / 9562 (0.03%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Anal fistula infection
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Appendiceal abscess
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis
subjects affected / exposed	13 / 9562 (0.14%)	10 / 9531 (0.10%)
occurrences causally related to treatment / all	0 / 14	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis perforated
subjects affected / exposed	3 / 9562 (0.03%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis infective
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Atypical pneumonia
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bacteraemia
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bacterial diarrhoea
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bacterial sepsis
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary sepsis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Brain abscess
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Breast abscess
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cellulitis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchiolitis
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	18 / 9562 (0.19%)	22 / 9531 (0.23%)
occurrences causally related to treatment / all	0 / 18	0 / 23
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis bacterial
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bursitis infective
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Campylobacter gastroenteritis
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	35 / 9562 (0.37%)	45 / 9531 (0.47%)
occurrences causally related to treatment / all	0 / 40	0 / 51
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis gangrenous
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis of male external genital organ
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cholangitis infective
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis infective
subjects affected / exposed	3 / 9562 (0.03%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic sinusitis
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Clostridium difficile colitis
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Clostridium difficile infection
subjects affected / exposed	2 / 9562 (0.02%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Complicated appendicitis
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cystitis
subjects affected / exposed	4 / 9562 (0.04%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Dacryocystitis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dengue fever
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dengue haemorrhagic fever
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Device related infection
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Device related sepsis
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic foot infection
subjects affected / exposed	3 / 9562 (0.03%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic gangrene
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea infectious
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulitis
subjects affected / exposed	11 / 9562 (0.12%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	1 / 12	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulitis intestinal haemorrhagic
subjects affected / exposed	3 / 9562 (0.03%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Dysentery
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ear infection
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Emphysematous cystitis
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Endocarditis
subjects affected / exposed	0 / 9562 (0.00%)	5 / 9531 (0.05%)
occurrences causally related to treatment / all	0 / 0	1 / 5
deaths causally related to treatment / all	0 / 0	1 / 2
Endophthalmitis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Enteritis infectious
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Enterobacter pneumonia
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Enterocolitis infectious
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Epididymitis
subjects affected / exposed	4 / 9562 (0.04%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Epiglottitis
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Erysipelas
subjects affected / exposed	12 / 9562 (0.13%)	10 / 9531 (0.10%)
occurrences causally related to treatment / all	0 / 12	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia urinary tract infection
subjects affected / exposed	2 / 9562 (0.02%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Eye infection viral
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Febrile infection
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Fungal infection
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gangrene
subjects affected / exposed	5 / 9562 (0.05%)	12 / 9531 (0.13%)
occurrences causally related to treatment / all	0 / 5	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	14 / 9562 (0.15%)	18 / 9531 (0.19%)
occurrences causally related to treatment / all	1 / 15	0 / 19
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis bacterial
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis salmonella
subjects affected / exposed	0 / 9562 (0.00%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis viral
subjects affected / exposed	3 / 9562 (0.03%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal infection
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Genitourinary tract infection
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Graft infection
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Groin abscess
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Helicobacter gastritis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Helicobacter infection
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Herpes ophthalmic
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Herpes virus infection
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Herpes zoster
subjects affected / exposed	5 / 9562 (0.05%)	5 / 9531 (0.05%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Incision site abscess
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infected bite
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infected cyst
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infected dermal cyst
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infected skin ulcer
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infection
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infectious colitis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infectious pleural effusion
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infective exacerbation of bronchiectasis
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Infective exacerbation of chronic obstructive airways disease
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Influenza
subjects affected / exposed	8 / 9562 (0.08%)	10 / 9531 (0.10%)
occurrences causally related to treatment / all	0 / 8	0 / 10
deaths causally related to treatment / all	0 / 1	0 / 0
Joint abscess
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Kidney infection
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Labyrinthitis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Liver abscess
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Localised infection
subjects affected / exposed	7 / 9562 (0.07%)	7 / 9531 (0.07%)
occurrences causally related to treatment / all	0 / 8	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Lower respiratory tract infection
subjects affected / exposed	4 / 9562 (0.04%)	5 / 9531 (0.05%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Ludwig angina
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lung abscess
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung infection
subjects affected / exposed	10 / 9562 (0.10%)	6 / 9531 (0.06%)
occurrences causally related to treatment / all	0 / 12	0 / 7
deaths causally related to treatment / all	0 / 1	0 / 0
Meningitis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Meningitis bacterial
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Meningococcal infection
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Necrotising fasciitis
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neutropenic sepsis
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal candidiasis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ophthalmic herpes zoster
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Orchitis
subjects affected / exposed	5 / 9562 (0.05%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteomyelitis
subjects affected / exposed	14 / 9562 (0.15%)	7 / 9531 (0.07%)
occurrences causally related to treatment / all	0 / 16	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Osteomyelitis acute
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteomyelitis chronic
subjects affected / exposed	3 / 9562 (0.03%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Otitis media
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Otitis media acute
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Otitis media chronic
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreas infection
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Papilloma viral infection
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Parainfluenzae virus infection
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Parotitis
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Perineal abscess
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Periodontitis
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Periorbital cellulitis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peritonitis
subjects affected / exposed	3 / 9562 (0.03%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Peritonitis bacterial
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peritonsillar abscess
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngeal abscess
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumocystis jirovecii infection
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	130 / 9562 (1.36%)	147 / 9531 (1.54%)
occurrences causally related to treatment / all	1 / 137	4 / 153
deaths causally related to treatment / all	0 / 9	0 / 10
Pneumonia bacterial
subjects affected / exposed	3 / 9562 (0.03%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia escherichia
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia influenzal
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia mycoplasmal
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia staphylococcal
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Pneumonia streptococcal
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia viral
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural infection
subjects affected / exposed	2 / 9562 (0.02%)	3 / 9531 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural sepsis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative abscess
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative wound infection
subjects affected / exposed	3 / 9562 (0.03%)	7 / 9531 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatic abscess
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis
subjects affected / exposed	8 / 9562 (0.08%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 8	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 0
Pyelonephritis acute
subjects affected / exposed	3 / 9562 (0.03%)	12 / 9531 (0.13%)
occurrences causally related to treatment / all	0 / 3	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis chronic
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal abscess
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory tract infection
subjects affected / exposed	4 / 9562 (0.04%)	5 / 9531 (0.05%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 0
Respiratory tract infection viral
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Salmonellosis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Scrotal abscess
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sepsis
subjects affected / exposed	14 / 9562 (0.15%)	20 / 9531 (0.21%)
occurrences causally related to treatment / all	0 / 15	0 / 20
deaths causally related to treatment / all	0 / 4	0 / 5
Septic shock
subjects affected / exposed	7 / 9562 (0.07%)	7 / 9531 (0.07%)
occurrences causally related to treatment / all	0 / 7	0 / 7
deaths causally related to treatment / all	0 / 3	0 / 2
Sinusitis
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Skin infection
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Soft tissue infection
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal infection
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal sepsis
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Streptococcal infection
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Streptococcal sepsis
subjects affected / exposed	4 / 9562 (0.04%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Subcutaneous abscess
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tonsillitis
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tooth abscess
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tracheobronchitis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tracheobronchitis mycoplasmal
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tuberculosis
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tuberculosis of genitourinary system
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Upper respiratory tract infection
subjects affected / exposed	3 / 9562 (0.03%)	5 / 9531 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Ureteritis
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	33 / 9562 (0.35%)	36 / 9531 (0.38%)
occurrences causally related to treatment / all	2 / 37	1 / 50
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection bacterial
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urosepsis
subjects affected / exposed	12 / 9562 (0.13%)	10 / 9531 (0.10%)
occurrences causally related to treatment / all	0 / 13	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 3
Vestibular neuronitis
subjects affected / exposed	1 / 9562 (0.01%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Viral infection
subjects affected / exposed	2 / 9562 (0.02%)	6 / 9531 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Vulval abscess
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vulval cellulitis
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wound infection
subjects affected / exposed	5 / 9562 (0.05%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Acute hepatitis B
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic hepatitis C
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
H1N1 influenza
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis A
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis C
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis E
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatitis Escherichia coli
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
West Nile viral infection
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dehydration
subjects affected / exposed	6 / 9562 (0.06%)	5 / 9531 (0.05%)
occurrences causally related to treatment / all	0 / 7	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetes mellitus
subjects affected / exposed	24 / 9562 (0.25%)	42 / 9531 (0.44%)
occurrences causally related to treatment / all	0 / 28	0 / 46
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetes mellitus inadequate control
subjects affected / exposed	50 / 9562 (0.52%)	60 / 9531 (0.63%)
occurrences causally related to treatment / all	0 / 55	0 / 78
deaths causally related to treatment / all	0 / 0	0 / 1
Diabetic complication
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic ketoacidosis
subjects affected / exposed	10 / 9562 (0.10%)	11 / 9531 (0.12%)
occurrences causally related to treatment / all	0 / 11	0 / 13
deaths causally related to treatment / all	0 / 2	0 / 0
Diabetic metabolic decompensation
subjects affected / exposed	9 / 9562 (0.09%)	17 / 9531 (0.18%)
occurrences causally related to treatment / all	0 / 9	0 / 17
deaths causally related to treatment / all	0 / 0	0 / 0
Euglycaemic diabetic ketoacidosis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fluid overload
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gout
subjects affected / exposed	5 / 9562 (0.05%)	6 / 9531 (0.06%)
occurrences causally related to treatment / all	1 / 7	3 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Hypercalcaemia
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperglycaemia
subjects affected / exposed	20 / 9562 (0.21%)	22 / 9531 (0.23%)
occurrences causally related to treatment / all	0 / 21	0 / 24
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperglycaemic hyperosmolar nonketotic syndrome
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperkalaemia
subjects affected / exposed	5 / 9562 (0.05%)	4 / 9531 (0.04%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertriglyceridaemia
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoglycaemia
subjects affected / exposed	33 / 9562 (0.35%)	25 / 9531 (0.26%)
occurrences causally related to treatment / all	0 / 39	0 / 26
deaths causally related to treatment / all	0 / 1	0 / 0
Hypokalaemia
subjects affected / exposed	2 / 9562 (0.02%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypomagnesaemia
subjects affected / exposed	1 / 9562 (0.01%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hyponatraemia
subjects affected / exposed	5 / 9562 (0.05%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypophosphataemia
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypovolaemia
subjects affected / exposed	0 / 9562 (0.00%)	2 / 9531 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ketoacidosis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lactic acidosis
subjects affected / exposed	2 / 9562 (0.02%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Metabolic acidosis
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Obesity
subjects affected / exposed	1 / 9562 (0.01%)	0 / 9531 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Type 2 diabetes mellitus
subjects affected / exposed	12 / 9562 (0.13%)	19 / 9531 (0.20%)
occurrences causally related to treatment / all	0 / 12	1 / 19
deaths causally related to treatment / all	0 / 0	0 / 0
Vitamin D deficiency
subjects affected / exposed	0 / 9562 (0.00%)	1 / 9531 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Ticagrelor	Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	1951 / 9562 (20.40%)	610 / 9531 (6.40%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea
subjects affected / exposed	1951 / 9562 (20.40%)	610 / 9531 (6.40%)
occurrences all number	2479	687

More information

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Were there any global substantial amendments to the protocol? Yes

11 May 2015

Ticagrelor dose changed from 90 mg bd to 60 mg bd. Changes in secondary objectives From: The secondary objectives of the study (presented in hierarchical order) are to compare the effect of long-term treatment with ticagrelor versus placebo for 1 Prevention of the composite of all-cause death, MI or stroke. 2 Prevention of CV death. 3 Prevention of all-cause death. To: The secondary objectives of the study (presented in hierarchical order) are to compare the effect of long-term treatment with ticagrelor versus placebo for 1 Prevention of CV death. 2 Prevention of MI. 3 Prevention of ischaemic stroke. 4 Prevention of all-cause death.

23 Sep 2015

An increase in number of patients to be enrolled in the study, and a change in the anticipated length of the study

07 Feb 2017

A change in the anticipated length of the study to increase the number of primary endpoint events collected. Inclusion of collection of concomitant medications at study closure visit.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

Overall 19271 patients were randomised to study drug, of which 51 patients were randomised to study drug at a site prematurely closed by sponsor and these patients were excluded from the study results.

http://www.ncbi.nlm.nih.gov/pubmed/30788847
http://www.ncbi.nlm.nih.gov/pubmed/31475798
http://www.ncbi.nlm.nih.gov/pubmed/31484629

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