Trial Outcomes & Findings for Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation (NCT NCT00781391)

NCT ID: NCT00781391

Last Updated: 2019-03-05

Results Overview

The composite of stroke and Systemic Embolic Events (SEE) during the on treatment period in the mITT analysis population with a non-inferiority analysis.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 21105 participants
• Primary outcome timeframe: on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up
• Results posted on: 2019-03-05

Participant Flow

Participant milestones

Measure	Warfarin/Placebo Edoxaban Warfarin tablets plus placebo Edoxaban tablets warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months placebo edoxaban: placebo edoxaban	High Dose Edoxaban/Placebo Warfarin Edoxaban tablets plus warfarin placebo tablets 60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	Low Dose Edoxaban/Placebo Warfarin Edoxaban tablets plus warfarin placebo tablets 30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin
Overall Study STARTED	7036	7035	7034
Overall Study Safety Analysis Set (Received Drug)	7012	7012	7002
Overall Study mITT Analysis Set (Received Drug)	7012	7012	7002
Overall Study Per Protocol Analysis Set	6993	6995	6982
Overall Study COMPLETED	6157	6228	6250
Overall Study NOT COMPLETED	879	807	784

Reasons for withdrawal

Measure	Warfarin/Placebo Edoxaban Warfarin tablets plus placebo Edoxaban tablets warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months placebo edoxaban: placebo edoxaban	High Dose Edoxaban/Placebo Warfarin Edoxaban tablets plus warfarin placebo tablets 60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	Low Dose Edoxaban/Placebo Warfarin Edoxaban tablets plus warfarin placebo tablets 30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin
Overall Study never received study drug	24	23	32
Overall Study Protocol Violation	19	17	20
Overall Study Death	789	730	706
Overall Study Withdrawal by Subject	47	37	25
Overall Study Lost to Follow-up	0	0	1

Baseline Characteristics

Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation

Baseline characteristics by cohort

Measure	Warfarin/Placebo Edoxaban n=7012 Participants Warfarin tablets plus placebo Edoxaban tablets warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months placebo edoxaban: placebo edoxaban	High Dose Edoxaban/Placebo Warfarin n=7012 Participants Edoxaban tablets plus warfarin placebo tablets 60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	Low Dose Edoxaban/Placebo Warfarin n=7002 Participants Edoxaban tablets plus warfarin placebo tablets 30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	Total n=21026 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	1869 Participants n=5 Participants	1830 Participants n=7 Participants	1784 Participants n=5 Participants	5483 Participants n=4 Participants
Age, Categorical >=65 years	5143 Participants n=5 Participants	5182 Participants n=7 Participants	5218 Participants n=5 Participants	15543 Participants n=4 Participants
Age, Continuous	70.5 years STANDARD_DEVIATION 9.44 • n=5 Participants	70.6 years STANDARD_DEVIATION 9.51 • n=7 Participants	70.6 years STANDARD_DEVIATION 9.31 • n=5 Participants	70.6 years STANDARD_DEVIATION 9.42 • n=4 Participants
Sex: Female, Male Female	2629 Participants n=5 Participants	2659 Participants n=7 Participants	2718 Participants n=5 Participants	8006 Participants n=4 Participants
Sex: Female, Male Male	4383 Participants n=5 Participants	4353 Participants n=7 Participants	4284 Participants n=5 Participants	13020 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	963 Participants n=5 Participants	956 Participants n=7 Participants	975 Participants n=5 Participants	2894 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	88 Participants n=5 Participants	96 Participants n=7 Participants	94 Participants n=5 Participants	278 Participants n=4 Participants
Race (NIH/OMB) White	5679 Participants n=5 Participants	5679 Participants n=7 Participants	5650 Participants n=5 Participants	17008 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	282 Participants n=5 Participants	281 Participants n=7 Participants	283 Participants n=5 Participants	846 Participants n=4 Participants
Region of Enrollment Portugal	46 participants n=5 Participants	71 participants n=7 Participants	61 participants n=5 Participants	178 participants n=4 Participants
Region of Enrollment United States	1297 participants n=5 Participants	1288 participants n=7 Participants	1308 participants n=5 Participants	3893 participants n=4 Participants
Region of Enrollment Serbia	95 participants n=5 Participants	107 participants n=7 Participants	74 participants n=5 Participants	276 participants n=4 Participants
Region of Enrollment Philippines	43 participants n=5 Participants	36 participants n=7 Participants	45 participants n=5 Participants	124 participants n=4 Participants
Region of Enrollment Estonia	76 participants n=5 Participants	55 participants n=7 Participants	60 participants n=5 Participants	191 participants n=4 Participants
Region of Enrollment Taiwan	77 participants n=5 Participants	72 participants n=7 Participants	85 participants n=5 Participants	234 participants n=4 Participants
Region of Enrollment Slovakia	143 participants n=5 Participants	133 participants n=7 Participants	129 participants n=5 Participants	405 participants n=4 Participants
Region of Enrollment Greece	14 participants n=5 Participants	27 participants n=7 Participants	9 participants n=5 Participants	50 participants n=4 Participants
Region of Enrollment Spain	44 participants n=5 Participants	65 participants n=7 Participants	54 participants n=5 Participants	163 participants n=4 Participants
Region of Enrollment Thailand	40 participants n=5 Participants	40 participants n=7 Participants	33 participants n=5 Participants	113 participants n=4 Participants
Region of Enrollment Ukraine	360 participants n=5 Participants	386 participants n=7 Participants	402 participants n=5 Participants	1148 participants n=4 Participants
Region of Enrollment Israel	104 participants n=5 Participants	88 participants n=7 Participants	88 participants n=5 Participants	280 participants n=4 Participants
Region of Enrollment Chile	74 participants n=5 Participants	91 participants n=7 Participants	88 participants n=5 Participants	253 participants n=4 Participants
Region of Enrollment Russian Federation	375 participants n=5 Participants	406 participants n=7 Participants	369 participants n=5 Participants	1150 participants n=4 Participants
Region of Enrollment Colombia	51 participants n=5 Participants	42 participants n=7 Participants	48 participants n=5 Participants	141 participants n=4 Participants
Region of Enrollment Switzerland	0 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants	5 participants n=4 Participants
Region of Enrollment Italy	60 participants n=5 Participants	55 participants n=7 Participants	54 participants n=5 Participants	169 participants n=4 Participants
Region of Enrollment India	232 participants n=5 Participants	220 participants n=7 Participants	234 participants n=5 Participants	686 participants n=4 Participants
Region of Enrollment France	40 participants n=5 Participants	38 participants n=7 Participants	32 participants n=5 Participants	110 participants n=4 Participants
Region of Enrollment Peru	64 participants n=5 Participants	46 participants n=7 Participants	60 participants n=5 Participants	170 participants n=4 Participants
Region of Enrollment Denmark	68 participants n=5 Participants	80 participants n=7 Participants	70 participants n=5 Participants	218 participants n=4 Participants
Region of Enrollment Australia	30 participants n=5 Participants	40 participants n=7 Participants	32 participants n=5 Participants	102 participants n=4 Participants
Region of Enrollment South Africa	97 participants n=5 Participants	92 participants n=7 Participants	90 participants n=5 Participants	279 participants n=4 Participants
Region of Enrollment Netherlands	64 participants n=5 Participants	49 participants n=7 Participants	40 participants n=5 Participants	153 participants n=4 Participants
Region of Enrollment China	163 participants n=5 Participants	150 participants n=7 Participants	152 participants n=5 Participants	465 participants n=4 Participants
Region of Enrollment Korea, Republic of	64 participants n=5 Participants	84 participants n=7 Participants	78 participants n=5 Participants	226 participants n=4 Participants
Region of Enrollment Finland	9 participants n=5 Participants	18 participants n=7 Participants	15 participants n=5 Participants	42 participants n=4 Participants
Region of Enrollment Guatemala	48 participants n=5 Participants	48 participants n=7 Participants	39 participants n=5 Participants	135 participants n=4 Participants
Region of Enrollment Turkey	40 participants n=5 Participants	39 participants n=7 Participants	31 participants n=5 Participants	110 participants n=4 Participants
Region of Enrollment United Kingdom	132 participants n=5 Participants	121 participants n=7 Participants	145 participants n=5 Participants	398 participants n=4 Participants
Region of Enrollment Hungary	151 participants n=5 Participants	143 participants n=7 Participants	167 participants n=5 Participants	461 participants n=4 Participants
Region of Enrollment Czech Republic	410 participants n=5 Participants	369 participants n=7 Participants	386 participants n=5 Participants	1165 participants n=4 Participants
Region of Enrollment Mexico	60 participants n=5 Participants	70 participants n=7 Participants	60 participants n=5 Participants	190 participants n=4 Participants
Region of Enrollment Canada	259 participants n=5 Participants	271 participants n=7 Participants	242 participants n=5 Participants	772 participants n=4 Participants
Region of Enrollment Argentina	352 participants n=5 Participants	345 participants n=7 Participants	362 participants n=5 Participants	1059 participants n=4 Participants
Region of Enrollment Brazil	236 participants n=5 Participants	242 participants n=7 Participants	225 participants n=5 Participants	703 participants n=4 Participants
Region of Enrollment Belgium	41 participants n=5 Participants	44 participants n=7 Participants	64 participants n=5 Participants	149 participants n=4 Participants
Region of Enrollment Poland	395 participants n=5 Participants	424 participants n=7 Participants	454 participants n=5 Participants	1273 participants n=4 Participants
Region of Enrollment Croatia	53 participants n=5 Participants	33 participants n=7 Participants	39 participants n=5 Participants	125 participants n=4 Participants
Region of Enrollment Romania	141 participants n=5 Participants	144 participants n=7 Participants	124 participants n=5 Participants	409 participants n=4 Participants
Region of Enrollment Bulgaria	179 participants n=5 Participants	174 participants n=7 Participants	165 participants n=5 Participants	518 participants n=4 Participants
Region of Enrollment Norway	11 participants n=5 Participants	8 participants n=7 Participants	15 participants n=5 Participants	34 participants n=4 Participants
Region of Enrollment Germany	308 participants n=5 Participants	293 participants n=7 Participants	307 participants n=5 Participants	908 participants n=4 Participants
Region of Enrollment Japan	337 participants n=5 Participants	336 participants n=7 Participants	337 participants n=5 Participants	1010 participants n=4 Participants
Region of Enrollment New Zealand	40 participants n=5 Participants	50 participants n=7 Participants	40 participants n=5 Participants	130 participants n=4 Participants
Region of Enrollment Sweden	89 participants n=5 Participants	78 participants n=7 Participants	86 participants n=5 Participants	253 participants n=4 Participants

PRIMARY outcome

Timeframe: on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up

Population: mITT (modified Intent To Treat) Analysis set; which included randomized subjects who received 1 or more dose of study drug. The time period included the subject was taking study drug and up to 3 days after their last dose (On-Treatment ).

The composite of stroke and Systemic Embolic Events (SEE) during the on treatment period in the mITT analysis population with a non-inferiority analysis.

Outcome measures

Measure	Low Dose Edoxaban/Placebo Warfarin n=7002 Participants Edoxaban tablets plus warfarin placebo tablets 30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	High Dose Edoxaban/Placebo Warfarin n=7012 Participants Edoxaban tablets plus warfarin placebo tablets 60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	Warfarin/Placebo Edoxaban n=7012 Participants Warfarin tablets plus placebo Edoxaban tablets warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months placebo edoxaban: placebo edoxaban
Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).	253 number of participants with event	182 number of participants with event	232 number of participants with event

PRIMARY outcome

Timeframe: overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up

Population: mITT (modified Intent To Treat) Analysis set; which included randomized subjects who received 1 or more dose of study drug. The time frame included overall study period (first dose to end of study).

The composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the mITT analysis population.

Outcome measures

Measure	Low Dose Edoxaban/Placebo Warfarin n=7002 Participants Edoxaban tablets plus warfarin placebo tablets 30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	High Dose Edoxaban/Placebo Warfarin n=7012 Participants Edoxaban tablets plus warfarin placebo tablets 60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	Warfarin/Placebo Edoxaban n=7012 Participants Warfarin tablets plus placebo Edoxaban tablets warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months placebo edoxaban: placebo edoxaban
Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).	382 Number of participants with event	292 Number of participants with event	336 Number of participants with event

PRIMARY outcome

Timeframe: on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up

Population: PP (Per Protocol) Analysis set; which included all randomized subjects who received at least 1 dose of randomized study drug and did not have any major protocol violations. The time period included the time the subject was taking study drug and up to 3 days after their last dose (On Treatment Period).

The composite of stroke and Systemic Embolic Events (SEE) during the on treatment period in the PP (per protocol) analysis set population.

Outcome measures

Measure	Low Dose Edoxaban/Placebo Warfarin n=6982 Participants Edoxaban tablets plus warfarin placebo tablets 30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	High Dose Edoxaban/Placebo Warfarin n=6995 Participants Edoxaban tablets plus warfarin placebo tablets 60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	Warfarin/Placebo Edoxaban n=6996 Participants Warfarin tablets plus placebo Edoxaban tablets warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months placebo edoxaban: placebo edoxaban
Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).	253 number of participants with event	182 number of participants with event	231 number of participants with event

PRIMARY outcome

Timeframe: overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up

Population: PP (per Protocol) Analysis set; which included all randomized subjects who received 1 or more dose of study drug for the overall study period (first dose to end of study) and did not have any major protocol violations. The time period included from the reference date (initial dose of study drug date) to the common study end date (CSED) Visit.

The composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the PP (per protocol) analysis set population.

Outcome measures

Measure	Low Dose Edoxaban/Placebo Warfarin n=6982 Participants Edoxaban tablets plus warfarin placebo tablets 30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	High Dose Edoxaban/Placebo Warfarin n=6995 Participants Edoxaban tablets plus warfarin placebo tablets 60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	Warfarin/Placebo Edoxaban n=6993 Participants Warfarin tablets plus placebo Edoxaban tablets warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months placebo edoxaban: placebo edoxaban
Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).	382 number of participants with event	292 number of participants with event	335 number of participants with event

PRIMARY outcome

Timeframe: overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up

Population: ITT (Intent To Treat) Analysis set; which included all randomized subjects whether or not they received a single dose of randomized study drug. The time frame included from reference date (randomization date) to the common study end date (CSED) Visit.

Compare edoxaban to warfarin for the composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the ITT analysis set with a superiority analysis.

Outcome measures

Measure	Low Dose Edoxaban/Placebo Warfarin n=7034 Participants Edoxaban tablets plus warfarin placebo tablets 30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	High Dose Edoxaban/Placebo Warfarin n=7035 Participants Edoxaban tablets plus warfarin placebo tablets 60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	Warfarin/Placebo Edoxaban n=7036 Participants Warfarin tablets plus placebo Edoxaban tablets warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months placebo edoxaban: placebo edoxaban
Compare Edoxaban to Warfarin for Superiority for Composite of Stroke and Systemic Embolic Events (SEE).	383 number of participants with event	296 number of participants with event	337 number of participants with event

SECONDARY outcome

Timeframe: overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up

Population: ITT (Intent To Treat) Analysis set; overall study period, which included all randomized subjects whether or not they received a single dose of randomized study drug. The time frame included from reference date (randomization date) to the common study end date (CSED) Visit..

Compare edoxaban to warfarin for the composite of stroke, Systemic Embolic Events, and Cardiovascular mortality during the overall study period in the ITT analysis set.

Outcome measures

Measure	Low Dose Edoxaban/Placebo Warfarin n=7034 Participants Edoxaban tablets plus warfarin placebo tablets 30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	High Dose Edoxaban/Placebo Warfarin n=7035 Participants Edoxaban tablets plus warfarin placebo tablets 60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	Warfarin/Placebo Edoxaban n=7036 Participants Warfarin tablets plus placebo Edoxaban tablets warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months placebo edoxaban: placebo edoxaban
Compare Edoxaban to Warfarin for Composite of Stroke, Systemic Embolic Event (SEE), and Cardiovascular (CV) Mortality	796 number of participants with event	728 number of participants with event	831 number of participants with event

SECONDARY outcome

Timeframe: overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up

Population: ITT overall study period, which included all randomized subjects whether or not they received a single dose of randomized study drug. The time frame included from the reference date (randomization date) to the common study end date (CSED) Visit.

Compare edoxaban to warfarin for Major Adverse Cardiac Event (MACE): a composite of non-fatal Myocardial Infarction, non-fatal stroke, non-fatal Systemic Embolic Events, and death due to Cardiovascular cause or bleeding during the overall study period in the ITT analysis set.

Outcome measures

Measure	Low Dose Edoxaban/Placebo Warfarin n=7034 Participants Edoxaban tablets plus warfarin placebo tablets 30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	High Dose Edoxaban/Placebo Warfarin n=7035 Participants Edoxaban tablets plus warfarin placebo tablets 60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	Warfarin/Placebo Edoxaban n=7036 Participants Warfarin tablets plus placebo Edoxaban tablets warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months placebo edoxaban: placebo edoxaban
Compare Edoxaban to Warfarin for Major Adverse Cardiac Event (MACE): a Composite of Non-fatal MI, Non-fatal Stroke, Non-fatal SEE, and Death Due to CV Cause or Bleeding	913 number of participants with event	827 number of participants with event	926 number of participants with event

SECONDARY outcome

Timeframe: overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up

Population: ITT overall study period, which included all randomized subjects whether or not they received a single dose of randomized study drug. The time frame included from the reference date (randomization date) to the common study end date (CSED) Visit.

Compare Edoxaban to warfarin for Composite of stroke, Systemic Embolic Events, and all-cause mortality during the overall study period in the ITT analysis set.

Outcome measures

Measure	Low Dose Edoxaban/Placebo Warfarin n=7034 Participants Edoxaban tablets plus warfarin placebo tablets 30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	High Dose Edoxaban/Placebo Warfarin n=7035 Participants Edoxaban tablets plus warfarin placebo tablets 60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	Warfarin/Placebo Edoxaban n=7036 Participants Warfarin tablets plus placebo Edoxaban tablets warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months placebo edoxaban: placebo edoxaban
Compare Edoxaban to Warfarin for Composite of Stroke, SEE, and All-cause Mortality	985 number of participants with event	949 number of participants with event	1046 number of participants with event

SECONDARY outcome

Timeframe: on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up

Population: Safety-analysis set, on-treatment period

Compare edoxaban versus warfarin for Adjudicated Bleeding Events during the on-treatment period in the Safety Analysis set.

Major bleeding was adjudicated by the Clinical Events Committee (CEC) and defined based on published guidance from the International Society on Thrombosis and Haemostasis (ISTH), with minor modifications for Hgb decrease and blood transfusion requirements.

Outcome measures

Measure	Low Dose Edoxaban/Placebo Warfarin n=7002 Participants Edoxaban tablets plus warfarin placebo tablets 30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	High Dose Edoxaban/Placebo Warfarin n=7012 Participants Edoxaban tablets plus warfarin placebo tablets 60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	Warfarin/Placebo Edoxaban n=7012 Participants Warfarin tablets plus placebo Edoxaban tablets warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months placebo edoxaban: placebo edoxaban
Adjudicated Bleeding Events Major bleed	254 number of participants with event	418 number of participants with event	524 number of participants with event
Adjudicated Bleeding Events ICH Major bleed	41 number of participants with event	61 number of participants with event	132 number of participants with event
Adjudicated Bleeding Events Non-ICH Major bleed	214 number of participants with event	359 number of participants with event	398 number of participants with event
Adjudicated Bleeding Events Fatal bleed	21 number of participants with event	32 number of participants with event	59 number of participants with event
Adjudicated Bleeding Events non-fatal (Major) bleed	234 number of participants with event	386 number of participants with event	466 number of participants with event
Adjudicated Bleeding Events life-threatening bleed	40 number of participants with event	62 number of participants with event	122 number of participants with event
Adjudicated Bleeding Events clinically relevant non-major bleed	969 number of participants with event	1214 number of participants with event	1396 number of participants with event
Adjudicated Bleeding Events major or clinically relevant non-major	1161 number of participants with event	1528 number of participants with event	1761 number of participants with event
Adjudicated Bleeding Events minor	533 number of participants with event	604 number of participants with event	714 number of participants with event
Adjudicated Bleeding Events any confirmed bleed	1499 number of participants with event	1865 number of participants with event	2114 number of participants with event

Adverse Events

Warfarin/Placebo Edoxaban

Serious events: 3581 serious events

Other events: 4200 other events

Deaths: 0 deaths

High Dose Edoxaban/Placebo Warfarin

Serious events: 3393 serious events

Other events: 4201 other events

Deaths: 0 deaths

Low Dose Edoxaban/Placebo Warfarin

Serious events: 3448 serious events

Other events: 4057 other events

Deaths: 0 deaths

Serious adverse events

Measure	Warfarin/Placebo Edoxaban n=7012 participants at risk Warfarin tablets plus placebo Edoxaban tablets warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months placebo edoxaban: placebo edoxaban	High Dose Edoxaban/Placebo Warfarin n=7012 participants at risk Edoxaban tablets plus warfarin placebo tablets Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	Low Dose Edoxaban/Placebo Warfarin n=7002 participants at risk Edoxaban tablets plus warfarin placebo tablets Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin
Nervous system disorders VASCULAR DEMENTIA	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders VERTIGO CNS ORIGIN	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders ACOUSTIC NEURITIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PITUITARY TUMOUR BENIGN	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Gastrointestinal disorders VOLVULUS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Hepatobiliary disorders CHOLELITHIASIS	0.36% 25/7012 • Number of events 27 • On treatment (safety analysis set)	0.37% 26/7012 • Number of events 27 • On treatment (safety analysis set)	0.44% 31/7002 • Number of events 31 • On treatment (safety analysis set)
Hepatobiliary disorders CHOLECYSTITIS	0.33% 23/7012 • Number of events 23 • On treatment (safety analysis set)	0.36% 25/7012 • Number of events 27 • On treatment (safety analysis set)	0.21% 15/7002 • Number of events 15 • On treatment (safety analysis set)
Hepatobiliary disorders CHOLECYSTITIS ACUTE	0.26% 18/7012 • Number of events 18 • On treatment (safety analysis set)	0.31% 22/7012 • Number of events 23 • On treatment (safety analysis set)	0.26% 18/7002 • Number of events 20 • On treatment (safety analysis set)
Hepatobiliary disorders BILE DUCT STONE	0.21% 15/7012 • Number of events 15 • On treatment (safety analysis set)	0.13% 9/7012 • Number of events 10 • On treatment (safety analysis set)	0.16% 11/7002 • Number of events 12 • On treatment (safety analysis set)
Hepatobiliary disorders HEPATIC CIRRHOSIS	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.10% 7/7012 • Number of events 7 • On treatment (safety analysis set)	0.13% 9/7002 • Number of events 9 • On treatment (safety analysis set)
Hepatobiliary disorders CHOLECYSTITIS CHRONIC	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Hepatobiliary disorders JAUNDICE	0.00% 0/7012 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Hepatobiliary disorders AUTOIMMUNE HEPATITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RECTAL ADENOMA	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Eye disorders BLEPHARITIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Cardiac disorders COR PULMONALE	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 2 • On treatment (safety analysis set)
Cardiac disorders CARDIAC DISORDER	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Cardiac disorders INTRACARDIAC THROMBUS	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Cardiac disorders PERICARDITIS	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Hepatobiliary disorders HEPATITIS CHRONIC ACTIVE	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 4 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders AORTIC DISSECTION	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Vascular disorders FEMORAL ARTERIAL STENOSIS	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Vascular disorders HAEMORRHAGE	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 4 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders HYPERTENSIVE EMERGENCY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Vascular disorders PERIPHERAL EMBOLISM	0.04% 3/7012 • Number of events 4 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.10% 7/7002 • Number of events 8 • On treatment (safety analysis set)
Vascular disorders THROMBOSIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Vascular disorders ARTERIAL DISORDER	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Vascular disorders ARTERIAL THROMBOSIS LIMB	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 4 • On treatment (safety analysis set)
Vascular disorders ARTERITIS OBLITERANS	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders DISTRIBUTIVE SHOCK	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders EXTREMITY NECROSIS	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Vascular disorders FEMORAL ARTERY EMBOLISM	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Vascular disorders INTRA-ABDOMINAL HAEMATOMA	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders SUBCLAVIAN VEIN THROMBOSIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders VENOUS INSUFFICIENCY	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Vascular disorders VENOUS THROMBOSIS	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Vascular disorders VENOUS THROMBOSIS LIMB	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Vascular disorders AORTIC DILATATION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders AORTIC THROMBOSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders ARTERIAL OCCLUSIVE DISEASE	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.09% 6/7002 • Number of events 6 • On treatment (safety analysis set)
Vascular disorders ARTERIAL THROMBOSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Vascular disorders CIRCULATORY COLLAPSE	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Vascular disorders DIABETIC MACROANGIOPATHY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders DIABETIC VASCULAR DISORDER	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders EMBOLISM ARTERIAL	0.09% 6/7012 • Number of events 7 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 2 • On treatment (safety analysis set)
Vascular disorders EXTRAVASATION BLOOD	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders FEMORAL ARTERY ANEURYSM	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders FEMORAL ARTERY OCCLUSION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Vascular disorders HAEMATOMA	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders HYPOVOLAEMIC SHOCK	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Vascular disorders ILIAC ARTERY EMBOLISM	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders INFARCTION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders INTERMITTENT CLAUDICATION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Vascular disorders ISCHAEMIA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Vascular disorders LYMPHATIC FISTULA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders LYMPHOCELE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders LYMPHOEDEMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Vascular disorders PERIPHERAL ARTERY ANEURYSM	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Vascular disorders RHEUMATOID VASCULITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders SHOCK HAEMORRHAGIC	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Vascular disorders SUBCLAVIAN STEAL SYNDROME	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders SUPERIOR MESENTERIC ARTERY SYNDROME	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders THROMBOPHLEBITIS	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders VARICOSE ULCERATION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders VASCULAR INSUFFICIENCY	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders VASCULITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Vascular disorders ACCELERATED HYPERTENSION	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 6 • On treatment (safety analysis set)
Vascular disorders ANEURYSM	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Vascular disorders ANEURYSM RUPTURED	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders ANGIOPATHY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders AORTIC DISSECTION RUPTURE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders AORTIC EMBOLUS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders AORTIC RUPTURE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders ARTERIAL HAEMORRHAGE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Vascular disorders ARTERIAL STENOSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Vascular disorders ARTERIAL STENOSIS LIMB	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders ARTERIOSCLEROSIS MOENCKEBERG-TYPE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders EMBOLISM	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Vascular disorders ESSENTIAL HYPERTENSION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Vascular disorders FIBROMUSCULAR DYSPLASIA	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LARYNGEAL PAPILLOMA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders HAEMODYNAMIC INSTABILITY	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Vascular disorders ILIAC ARTERY STENOSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Vascular disorders ILIAC ARTERY THROMBOSIS	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders LABILE HYPERTENSION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders POOR PERIPHERAL CIRCULATION	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Vascular disorders SHOCK	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Vascular disorders TEMPORAL ARTERITIS	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders THROMBOANGIITIS OBLITERANS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Vascular disorders THROMBOPHLEBITIS SUPERFICIAL	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders THROMBOSED VARICOSE VEIN	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders VENOUS HAEMORRHAGE	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	1.3% 89/7012 • Number of events 127 • On treatment (safety analysis set)	1.3% 93/7012 • Number of events 125 • On treatment (safety analysis set)	1.5% 105/7002 • Number of events 150 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.68% 48/7012 • Number of events 56 • On treatment (safety analysis set)	0.51% 36/7012 • Number of events 42 • On treatment (safety analysis set)	0.26% 18/7002 • Number of events 18 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	0.29% 20/7012 • Number of events 21 • On treatment (safety analysis set)	0.41% 29/7012 • Number of events 29 • On treatment (safety analysis set)	0.37% 26/7002 • Number of events 26 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.26% 18/7012 • Number of events 19 • On treatment (safety analysis set)	0.37% 26/7012 • Number of events 27 • On treatment (safety analysis set)	0.29% 20/7002 • Number of events 24 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.37% 26/7012 • Number of events 28 • On treatment (safety analysis set)	0.30% 21/7012 • Number of events 22 • On treatment (safety analysis set)	0.37% 26/7002 • Number of events 26 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY FAILURE	0.27% 19/7012 • Number of events 19 • On treatment (safety analysis set)	0.29% 20/7012 • Number of events 23 • On treatment (safety analysis set)	0.24% 17/7002 • Number of events 17 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders HAEMOPTYSIS	0.20% 14/7012 • Number of events 14 • On treatment (safety analysis set)	0.29% 20/7012 • Number of events 23 • On treatment (safety analysis set)	0.14% 10/7002 • Number of events 10 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.27% 19/7012 • Number of events 22 • On treatment (safety analysis set)	0.20% 14/7012 • Number of events 16 • On treatment (safety analysis set)	0.33% 23/7002 • Number of events 24 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders ASTHMA	0.27% 19/7012 • Number of events 28 • On treatment (safety analysis set)	0.19% 13/7012 • Number of events 13 • On treatment (safety analysis set)	0.27% 19/7002 • Number of events 22 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders PNEUMONIA ASPIRATION	0.20% 14/7012 • Number of events 15 • On treatment (safety analysis set)	0.19% 13/7012 • Number of events 13 • On treatment (safety analysis set)	0.30% 21/7002 • Number of events 24 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	0.11% 8/7012 • Number of events 8 • On treatment (safety analysis set)	0.17% 12/7012 • Number of events 14 • On treatment (safety analysis set)	0.17% 12/7002 • Number of events 12 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders ACUTE PULMONARY OEDEMA	0.11% 8/7012 • Number of events 9 • On treatment (safety analysis set)	0.16% 11/7012 • Number of events 12 • On treatment (safety analysis set)	0.11% 8/7002 • Number of events 8 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders INTERSTITIAL LUNG DISEASE	0.06% 4/7012 • Number of events 5 • On treatment (safety analysis set)	0.13% 9/7012 • Number of events 11 • On treatment (safety analysis set)	0.11% 8/7002 • Number of events 8 • On treatment (safety analysis set)
Infections and infestations PNEUMONIA	3.7% 262/7012 • Number of events 292 • On treatment (safety analysis set)	3.7% 259/7012 • Number of events 298 • On treatment (safety analysis set)	3.1% 219/7002 • Number of events 237 • On treatment (safety analysis set)
Infections and infestations URINARY TRACT INFECTION	1.1% 78/7012 • Number of events 86 • On treatment (safety analysis set)	0.86% 60/7012 • Number of events 75 • On treatment (safety analysis set)	0.81% 57/7002 • Number of events 62 • On treatment (safety analysis set)
Infections and infestations BRONCHITIS	0.86% 60/7012 • Number of events 64 • On treatment (safety analysis set)	0.80% 56/7012 • Number of events 58 • On treatment (safety analysis set)	0.81% 57/7002 • Number of events 63 • On treatment (safety analysis set)
Infections and infestations CELLULITIS	0.88% 62/7012 • Number of events 71 • On treatment (safety analysis set)	0.74% 52/7012 • Number of events 64 • On treatment (safety analysis set)	0.84% 59/7002 • Number of events 69 • On treatment (safety analysis set)
Infections and infestations SEPSIS	0.50% 35/7012 • Number of events 35 • On treatment (safety analysis set)	0.54% 38/7012 • Number of events 39 • On treatment (safety analysis set)	0.61% 43/7002 • Number of events 44 • On treatment (safety analysis set)
Infections and infestations GASTROENTERITIS	0.43% 30/7012 • Number of events 31 • On treatment (safety analysis set)	0.39% 27/7012 • Number of events 29 • On treatment (safety analysis set)	0.41% 29/7002 • Number of events 29 • On treatment (safety analysis set)
Infections and infestations LOBAR PNEUMONIA	0.34% 24/7012 • Number of events 25 • On treatment (safety analysis set)	0.33% 23/7012 • Number of events 24 • On treatment (safety analysis set)	0.33% 23/7002 • Number of events 23 • On treatment (safety analysis set)
Infections and infestations BRONCHOPNEUMONIA	0.50% 35/7012 • Number of events 35 • On treatment (safety analysis set)	0.31% 22/7012 • Number of events 24 • On treatment (safety analysis set)	0.41% 29/7002 • Number of events 29 • On treatment (safety analysis set)
Infections and infestations DIVERTICULITIS	0.31% 22/7012 • Number of events 26 • On treatment (safety analysis set)	0.21% 15/7012 • Number of events 15 • On treatment (safety analysis set)	0.14% 10/7002 • Number of events 10 • On treatment (safety analysis set)
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	0.11% 8/7012 • Number of events 8 • On treatment (safety analysis set)	0.21% 15/7012 • Number of events 17 • On treatment (safety analysis set)	0.20% 14/7002 • Number of events 14 • On treatment (safety analysis set)
Infections and infestations SEPTIC SHOCK	0.39% 27/7012 • Number of events 27 • On treatment (safety analysis set)	0.20% 14/7012 • Number of events 14 • On treatment (safety analysis set)	0.23% 16/7002 • Number of events 16 • On treatment (safety analysis set)
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.10% 7/7012 • Number of events 8 • On treatment (safety analysis set)	0.17% 12/7012 • Number of events 12 • On treatment (safety analysis set)	0.14% 10/7002 • Number of events 10 • On treatment (safety analysis set)
Infections and infestations ERYSIPELAS	0.21% 15/7012 • Number of events 19 • On treatment (safety analysis set)	0.16% 11/7012 • Number of events 12 • On treatment (safety analysis set)	0.27% 19/7002 • Number of events 19 • On treatment (safety analysis set)
Infections and infestations OSTEOMYELITIS	0.16% 11/7012 • Number of events 12 • On treatment (safety analysis set)	0.14% 10/7012 • Number of events 10 • On treatment (safety analysis set)	0.19% 13/7002 • Number of events 16 • On treatment (safety analysis set)
Infections and infestations PNEUMONIA BACTERIAL	0.20% 14/7012 • Number of events 15 • On treatment (safety analysis set)	0.14% 10/7012 • Number of events 11 • On treatment (safety analysis set)	0.16% 11/7002 • Number of events 13 • On treatment (safety analysis set)
Infections and infestations APPENDICITIS	0.13% 9/7012 • Number of events 9 • On treatment (safety analysis set)	0.13% 9/7012 • Number of events 9 • On treatment (safety analysis set)	0.11% 8/7002 • Number of events 8 • On treatment (safety analysis set)
Infections and infestations PYELONEPHRITIS	0.19% 13/7012 • Number of events 17 • On treatment (safety analysis set)	0.13% 9/7012 • Number of events 9 • On treatment (safety analysis set)	0.07% 5/7002 • Number of events 5 • On treatment (safety analysis set)
Infections and infestations UROSEPSIS	0.19% 13/7012 • Number of events 13 • On treatment (safety analysis set)	0.13% 9/7012 • Number of events 10 • On treatment (safety analysis set)	0.27% 19/7002 • Number of events 22 • On treatment (safety analysis set)
Infections and infestations CYSTITIS	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.11% 8/7012 • Number of events 8 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations PYELONEPHRITIS ACUTE	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.11% 8/7012 • Number of events 8 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Infections and infestations GASTROENTERITIS VIRAL	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.10% 7/7012 • Number of events 8 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Infections and infestations POSTOPERATIVE WOUND INFECTION	0.09% 6/7012 • Number of events 7 • On treatment (safety analysis set)	0.10% 7/7012 • Number of events 7 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Infections and infestations CLOSTRIDIUM DIFFICILE COLITIS	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.09% 6/7012 • Number of events 8 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Infections and infestations GANGRENE	0.13% 9/7012 • Number of events 9 • On treatment (safety analysis set)	0.09% 6/7012 • Number of events 7 • On treatment (safety analysis set)	0.11% 8/7002 • Number of events 10 • On treatment (safety analysis set)
Infections and infestations INFECTION	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.09% 6/7002 • Number of events 6 • On treatment (safety analysis set)
Infections and infestations INFLUENZA	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.09% 6/7002 • Number of events 6 • On treatment (safety analysis set)
Infections and infestations LUNG INFECTION	0.09% 6/7012 • Number of events 7 • On treatment (safety analysis set)	0.09% 6/7012 • Number of events 7 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Infections and infestations CHOLECYSTITIS INFECTIVE	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Infections and infestations HERPES ZOSTER	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 6 • On treatment (safety analysis set)	0.13% 9/7002 • Number of events 9 • On treatment (safety analysis set)
Infections and infestations INFECTED SKIN ULCER	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.07% 5/7002 • Number of events 5 • On treatment (safety analysis set)
Infections and infestations INFECTIOUS PERITONITIS	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Infections and infestations RESPIRATORY TRACT INFECTION	0.13% 9/7012 • Number of events 9 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 6 • On treatment (safety analysis set)	0.11% 8/7002 • Number of events 8 • On treatment (safety analysis set)
Infections and infestations ENDOCARDITIS	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.09% 6/7002 • Number of events 6 • On treatment (safety analysis set)
Infections and infestations ORCHITIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 5 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Infections and infestations PULMONARY TUBERCULOSIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Infections and infestations STAPHYLOCOCCAL BACTERAEMIA	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations WOUND INFECTION	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Infections and infestations ABSCESS LIMB	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Infections and infestations BACTERIAL SEPSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Infections and infestations CLOSTRIDIAL INFECTION	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 4 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Infections and infestations GASTROENTERITIS SALMONELLA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations IMPLANT SITE INFECTION	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Infections and infestations STAPHYLOCOCCAL SEPSIS	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Infections and infestations TRACHEOBRONCHITIS	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Infections and infestations URINARY TRACT INFECTION PSEUDOMONAL	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations VIRAL INFECTION	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.09% 6/7002 • Number of events 6 • On treatment (safety analysis set)
Infections and infestations APPENDICITIS PERFORATED	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Infections and infestations ARTHRITIS BACTERIAL	0.11% 8/7012 • Number of events 8 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Infections and infestations BACTERAEMIA	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Infections and infestations BRONCHITIS BACTERIAL	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations CAMPYLOBACTER GASTROENTERITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations CREUTZFELDT-JAKOB DISEASE	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations DEVICE RELATED INFECTION	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 5 • On treatment (safety analysis set)
Infections and infestations DIABETIC GANGRENE	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 4 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Infections and infestations DIARRHOEA INFECTIOUS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Infections and infestations ENDOCARDITIS BACTERIAL	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Infections and infestations ENTEROCOLITIS INFECTIOUS	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations ESCHERICHIA SEPSIS	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Infections and infestations ESCHERICHIA URINARY TRACT INFECTION	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Infections and infestations HEPATITIS E	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations INTERVERTEBRAL DISCITIS	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Infections and infestations KLEBSIELLA BACTERAEMIA	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations LARYNGITIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations LOCALISED INFECTION	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Infections and infestations LUNG INFECTION PSEUDOMONAL	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Infections and infestations NECROTISING FASCIITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations PERIORBITAL CELLULITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations PERITONITIS BACTERIAL	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations PNEUMONIA PNEUMOCOCCAL	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Infections and infestations PULMONARY SEPSIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations SALMONELLOSIS	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations SCROTAL ABSCESS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations SINUSITIS	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Infections and infestations SOFT TISSUE INFECTION	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations STAPHYLOCOCCAL INFECTION	0.14% 10/7012 • Number of events 11 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.10% 7/7002 • Number of events 7 • On treatment (safety analysis set)
Infections and infestations STREPTOCOCCAL SEPSIS	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations TOOTH ABSCESS	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations TUBERCULOUS PLEURISY	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations URINARY TRACT INFECTION BACTERIAL	0.06% 4/7012 • Number of events 5 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Infections and infestations WOUND INFECTION STAPHYLOCOCCAL	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Infections and infestations ABDOMINAL ABSCESS	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Infections and infestations ABDOMINAL WALL ABSCESS	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations ABSCESS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations ABSCESS INTESTINAL	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations ACINETOBACTER BACTERAEMIA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations AMOEBIC COLITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations ANAL ABSCESS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Infections and infestations ARTERIOSCLEROTIC GANGRENE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations ARTHRITIS INFECTIVE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations ATYPICAL MYCOBACTERIAL PNEUMONIA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations BACTERIAL PROSTATITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations BACTEROIDES BACTERAEMIA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations BILIARY SEPSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Infections and infestations BRAIN ABSCESS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations BRONCHIOLITIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations CANDIDA PNEUMONIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations CELLULITIS STAPHYLOCOCCAL	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations CHOLANGITIS SUPPURATIVE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations CYSTITIS KLEBSIELLA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations DENGUE FEVER	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Infections and infestations DEVICE RELATED SEPSIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations DISSEMINATED TUBERCULOSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations ECZEMA INFECTED	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations EMPYEMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Infections and infestations ENCEPHALITIS VIRAL	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations ENTEROCOCCAL BACTERAEMIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Infections and infestations ENTEROCOCCAL INFECTION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations ENTEROCOCCAL SEPSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations ESCHERICHIA BACTERAEMIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations ESCHERICHIA INFECTION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations FEBRILE INFECTION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations FURUNCLE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations GAS GANGRENE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations GASTRIC ULCER HELICOBACTER	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations GASTRITIS VIRAL	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations GASTROENTERITIS AEROMONAS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations GROIN ABSCESS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Infections and infestations HAEMATOMA INFECTION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations HELICOBACTER GASTRITIS	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations HEPATIC CYST INFECTION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations HEPATITIS VIRAL	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations HERPES ZOSTER OPHTHALMIC	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations INFECTIOUS PLEURAL EFFUSION	0.04% 3/7012 • Number of events 4 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations INFECTIVE MYOSITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations INFUSION SITE INFECTION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations KLEBSIELLA SEPSIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Infections and infestations LABYRINTHITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations LOWER RESPIRATORY TRACT INFECTION BACTERIAL	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations LYMPH NODE TUBERCULOSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations MASTOIDITIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations MENINGITIS MENINGOCOCCAL	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations MYIASIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations NEUROCYSTICERCOSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations NEUTROPENIC SEPSIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations NOSOCOMIAL INFECTION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations ORAL CANDIDIASIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Infections and infestations PARAOESOPHAGEAL ABSCESS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations PERITONSILLAR ABSCESS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations PHARYNGITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Infections and infestations PNEUMONIA HAEMOPHILUS	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations PNEUMONIA NECROTISING	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations PNEUMONIA PRIMARY ATYPICAL	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations PNEUMONIA STAPHYLOCOCCAL	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations PNEUMONIA VIRAL	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations POST PROCEDURAL CELLULITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations PSEUDOMEMBRANOUS COLITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 3 • On treatment (safety analysis set)
Infections and infestations PSEUDOMONAL BACTERAEMIA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations PSEUDOMONAS BRONCHITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations PULMONARY TUBERCULOMA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations PYELONEPHRITIS CHRONIC	0.03% 2/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Infections and infestations SEPSIS SYNDROME	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations SEPTIC ARTHRITIS STREPTOCOCCAL	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations SEPTIC ARTHRITIS STAPHYLOCOCCAL	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations SIALOADENITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations SINOBRONCHITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations SKIN INFECTION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations STAPHYLOCOCCAL SKIN INFECTION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations STREPTOCOCCAL INFECTION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations SUBDIAPHRAGMATIC ABSCESS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations TOXIC SHOCK SYNDROME	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations VESTIBULAR NEURONITIS	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations VIRAL DIARRHOEA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations VIRAL LABYRINTHITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations VIRAL PHARYNGITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations WOUND SEPSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations ABDOMINAL SEPSIS	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations ABSCESS ORAL	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations ACARODERMATITIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations ACINETOBACTER INFECTION	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations AMERICAN TRYPANOSOMIASIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations BACTERIAL FOOD POISONING	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations BRONCHITIS VIRAL	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations BURSITIS INFECTIVE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations CAMPYLOBACTER INTESTINAL INFECTION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations CARBUNCLE	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations CELLULITIS GANGRENOUS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations CELLULITIS STREPTOCOCCAL	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations CHIKUNGUNYA VIRUS INFECTION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations CHRONIC SINUSITIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations CHRONIC TONSILLITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations CITROBACTER SEPSIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations CYSTITIS BACTERIAL	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations CYSTITIS ESCHERICHIA	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations DIABETIC FOOT INFECTION	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Infections and infestations DOUGLAS' ABSCESS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations EMPHYSEMATOUS CHOLECYSTITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations ENCEPHALITIS HERPES	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations ENDOCARDITIS ENTEROCOCCAL	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations ENTERITIS INFECTIOUS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations ENTEROBACTER BACTERAEMIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations ENTEROBACTER SEPSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations EPIGLOTTITIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations EXTRADURAL ABSCESS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations GASTROENTERITIS BACTERIAL	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations GASTROENTERITIS CLOSTRIDIAL	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations GASTROENTERITIS ROTAVIRUS	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations GASTROINTESTINAL INFECTION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Infections and infestations GINGIVAL ABSCESS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations GROIN INFECTION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations H1N1 INFLUENZA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations HAEMOPHILUS INFECTION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations HELICOBACTER INFECTION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations HEPATITIS B	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations HEPATITIS INFECTIOUS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations IMPLANT SITE ABSCESS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations INCISION SITE INFECTION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Infections and infestations INFECTED DERMAL CYST	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations JOINT ABSCESS	0.03% 2/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations KERATITIS HERPETIC	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations KIDNEY INFECTION	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Infections and infestations LEGIONELLA INFECTION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations LIVER ABSCESS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Infections and infestations LOWER RESPIRATORY TRACT INFECTION VIRAL	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations MALARIA	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations MENINGITIS ASEPTIC	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations MENINGITIS BACTERIAL	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations MENINGITIS STREPTOCOCCAL	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations MENINGITIS TUBERCULOUS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations MENINGITIS VIRAL	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations MOLLUSCUM CONTAGIOSUM	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations MURINE TYPHUS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations MUSCLE ABSCESS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Infections and infestations MYCOTOXICOSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations NEUROBORRELIOSIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations OESOPHAGEAL CANDIDIASIS	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations OSTEOMYELITIS CHRONIC	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations OTITIS MEDIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations OTITIS MEDIA ACUTE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations PARONYCHIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations PAROTITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations PERICORONITIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations PERIRECTAL ABSCESS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations PHARYNGITIS STREPTOCOCCAL	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations PLASMODIUM FALCIPARUM INFECTION	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations PNEUMONIA FUNGAL	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations PNEUMONIA INFLUENZAL	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations PNEUMONIA KLEBSIELLA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Infections and infestations PNEUMONIA LEGIONELLA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations PNEUMONIA MYCOPLASMAL	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Infections and infestations PNEUMONIA STREPTOCOCCAL	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Infections and infestations POST PROCEDURAL INFECTION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations POST PROCEDURAL PNEUMONIA	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations PROTEUS INFECTION	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations PSEUDOMONAS INFECTION	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Infections and infestations PSOAS ABSCESS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations RECTAL ABSCESS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations RENAL CYST INFECTION	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations RESPIRATORY TRACT INFECTION VIRAL	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations RETROPERITONEAL ABSCESS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations SEPTIC EMBOLUS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations SEPTIC ENCEPHALOPATHY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations SERRATIA SEPSIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations SPLENIC ABSCESS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations STREPTOCOCCAL BACTERAEMIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations SUBCUTANEOUS ABSCESS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Infections and infestations TUBERCULOSIS OF CENTRAL NERVOUS SYSTEM	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations TYPHOID FEVER	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations URINARY TRACT INFECTION ENTEROCOCCAL	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Infections and infestations VIRAL UPPER RESPIRATORY TRACT INFECTION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Infections and infestations VULVAL CELLULITIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER	0.46% 32/7012 • Number of events 32 • On treatment (safety analysis set)	0.48% 34/7012 • Number of events 34 • On treatment (safety analysis set)	0.49% 34/7002 • Number of events 34 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON CANCER	0.53% 37/7012 • Number of events 38 • On treatment (safety analysis set)	0.41% 29/7012 • Number of events 29 • On treatment (safety analysis set)	0.43% 30/7002 • Number of events 30 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BASAL CELL CARCINOMA	0.33% 23/7012 • Number of events 23 • On treatment (safety analysis set)	0.30% 21/7012 • Number of events 31 • On treatment (safety analysis set)	0.37% 26/7002 • Number of events 36 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER	0.26% 18/7012 • Number of events 18 • On treatment (safety analysis set)	0.26% 18/7012 • Number of events 18 • On treatment (safety analysis set)	0.27% 19/7002 • Number of events 19 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM MALIGNANT	0.21% 15/7012 • Number of events 15 • On treatment (safety analysis set)	0.23% 16/7012 • Number of events 16 • On treatment (safety analysis set)	0.19% 13/7002 • Number of events 13 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER CANCER	0.10% 7/7012 • Number of events 10 • On treatment (safety analysis set)	0.19% 13/7012 • Number of events 13 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 5 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GASTRIC CANCER	0.21% 15/7012 • Number of events 15 • On treatment (safety analysis set)	0.14% 10/7012 • Number of events 10 • On treatment (safety analysis set)	0.17% 12/7002 • Number of events 12 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON ADENOMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.13% 9/7012 • Number of events 9 • On treatment (safety analysis set)	0.09% 6/7002 • Number of events 6 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG ADENOCARCINOMA	0.11% 8/7012 • Number of events 8 • On treatment (safety analysis set)	0.13% 9/7012 • Number of events 9 • On treatment (safety analysis set)	0.09% 6/7002 • Number of events 6 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RECTAL CANCER	0.10% 7/7012 • Number of events 7 • On treatment (safety analysis set)	0.13% 9/7012 • Number of events 9 • On treatment (safety analysis set)	0.10% 7/7002 • Number of events 7 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER TRANSITIONAL CELL CARCINOMA	0.17% 12/7012 • Number of events 12 • On treatment (safety analysis set)	0.11% 8/7012 • Number of events 8 • On treatment (safety analysis set)	0.19% 13/7002 • Number of events 13 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATIC ADENOMA	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.11% 8/7012 • Number of events 8 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MYELODYSPLASTIC SYNDROME	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.10% 7/7012 • Number of events 7 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA	0.13% 9/7012 • Number of events 11 • On treatment (safety analysis set)	0.10% 7/7012 • Number of events 7 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 19 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HEPATIC NEOPLASM MALIGNANT	0.10% 7/7012 • Number of events 9 • On treatment (safety analysis set)	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.11% 8/7002 • Number of events 8 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT MELANOMA	0.10% 7/7012 • Number of events 7 • On treatment (safety analysis set)	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.09% 6/7002 • Number of events 6 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) UTERINE CANCER	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BRONCHIAL CARCINOMA	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADENOCARCINOMA PANCREAS	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-CELL LYMPHOMA	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OESOPHAGEAL ADENOCARCINOMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OESOPHAGEAL CARCINOMA	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.11% 8/7002 • Number of events 8 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PANCREATIC CARCINOMA	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.10% 7/7002 • Number of events 7 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL CELL CARCINOMA	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SMALL CELL LUNG CANCER STAGE UNSPECIFIED	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA OF SKIN	0.06% 4/7012 • Number of events 5 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.11% 8/7002 • Number of events 10 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TRANSITIONAL CELL CARCINOMA	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.07% 5/7002 • Number of events 5 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLORECTAL CANCER	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ENDOMETRIAL CANCER	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GASTRIC CANCER STAGE 0	0.01% 1/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GASTROINTESTINAL STROMAL TUMOUR	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LIPOMA	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG CANCER METASTATIC	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.07% 5/7002 • Number of events 5 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OESOPHAGEAL CANCER METASTATIC	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PANCREATIC CARCINOMA METASTATIC	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER METASTATIC	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL CANCER	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) THYROID CANCER	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ACUTE MYELOID LEUKAEMIA	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADENOCARCINOMA	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BILE DUCT CANCER	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER CANCER RECURRENT	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BRAIN NEOPLASM	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) DIFFUSE LARGE B-CELL LYMPHOMA	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) FIBROADENOMA OF BREAST	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GALLBLADDER CANCER	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GASTRIC NEOPLASM	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GASTROINTESTINAL TRACT ADENOMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LARYNGEAL CANCER	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LEIOMYOMA	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG ADENOCARCINOMA METASTATIC	0.01% 1/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LYMPHOMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MENINGIOMA BENIGN	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO LIVER	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTATIC GASTRIC CANCER	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEOPLASM MALIGNANT	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OVARIAN CANCER	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PANCREATIC NEOPLASM	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PARATHYROID TUMOUR BENIGN	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PLASMACYTOMA	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SKIN CANCER	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) URETERIC CANCER	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) UTERINE LEIOMYOMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ABDOMINAL NEOPLASM	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ACUTE PROMYELOCYTIC LEUKAEMIA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ANGIOSARCOMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BENIGN DUODENAL NEOPLASM	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BENIGN GASTRIC NEOPLASM	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BENIGN LUNG NEOPLASM	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BENIGN NEOPLASM OF ADRENAL GLAND	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BENIGN NEOPLASM OF BLADDER	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BENIGN NEOPLASM OF PROSTATE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BENIGN NEOPLASM OF URETHRA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BENIGN PANCREATIC NEOPLASM	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BENIGN SALIVARY GLAND NEOPLASM	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BENIGN URINARY TRACT NEOPLASM	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BILIARY NEOPLASM	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER NEOPLASM	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BONE CANCER METASTATIC	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BONE GIANT CELL TUMOUR BENIGN	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER STAGE II	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST NEOPLASM	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BRONCHIAL NEOPLASM	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON CANCER METASTATIC	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) FOLLICLE CENTRE LYMPHOMA, FOLLICULAR GRADE I, II, III STAGE III	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GASTRIC CANCER STAGE II	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GASTROINTESTINAL CARCINOMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GLIOBLASTOMA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HAEMANGIOMA OF SKIN	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HEAD AND NECK CANCER	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HEPATIC CANCER METASTATIC	0.03% 2/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HEPATIC NEOPLASM	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HODGKIN'S DISEASE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HYPOPHARYNGEAL CANCER	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) INTRADUCTAL PAPILLOMA OF BREAST	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) IRITIC MELANOMA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) KERATOACANTHOMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LARGE INTESTINE CARCINOMA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LIP AND/OR ORAL CAVITY CANCER	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG ADENOCARCINOMA STAGE IV	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE III	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LYMPHANGIOSIS CARCINOMATOSA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LYMPHOPLASMACYTOID LYMPHOMA/IMMUNOCYTOMA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT NEOPLASM OF PLEURA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT PALATE NEOPLASM	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT PLEURAL EFFUSION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MANTLE CELL LYMPHOMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MELANOMA RECURRENT	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MENINGIOMA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MESOTHELIOMA	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO BONE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO CENTRAL NERVOUS SYSTEM	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTATIC BRONCHIAL CARCINOMA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTATIC MALIGNANT MELANOMA	0.03% 2/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTATIC PAIN	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTATIC SQUAMOUS CELL CARCINOMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEOPLASM PROSTATE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEUROENDOCRINE TUMOUR	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NON-HODGKIN'S LYMPHOMA	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NON-HODGKIN'S LYMPHOMA STAGE I	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NON-SMALL CELL LUNG CANCER	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NON-SMALL CELL LUNG CANCER STAGE I	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OESOPHAGEAL ADENOCARCINOMA METASTATIC	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OESOPHAGEAL ADENOCARCINOMA STAGE II	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OESOPHAGEAL SQUAMOUS CELL CARCINOMA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ORAL PAPILLOMA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OVARIAN NEOPLASM	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PARANEOPLASTIC SYNDROME	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PARATHYROID TUMOUR MALIGNANT	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PHARYNGEAL NEOPLASM	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RECTAL CANCER STAGE I	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RECTOSIGMOID CANCER	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL ADENOMA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SEBORRHOEIC KERATOSIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SINONASAL PAPILLOMA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SMALL INTESTINE CARCINOMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) THYROID ADENOMA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TUMOUR HAEMORRHAGE	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) URINARY TRACT NEOPLASM	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ACUTE LYMPHOCYTIC LEUKAEMIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADRENAL CARCINOMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ANGIOSARCOMA METASTATIC	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BENIGN BILIARY NEOPLASM	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BENIGN BREAST NEOPLASM	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BENIGN COLONIC NEOPLASM	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BENIGN NEOPLASM	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 2 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BENIGN NEOPLASM OF CERVIX UTERI	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BENIGN NEOPLASM OF SKIN	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BENIGN NEOPLASM OF THYROID GLAND	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BENIGN PENILE NEOPLASM	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BENIGN RENAL NEOPLASM	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER PAPILLOMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER TRANSITIONAL CELL CARCINOMA RECURRENT	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BONE NEOPLASM	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BONE NEOPLASM MALIGNANT	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BOWEN'S DISEASE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BRAIN NEOPLASM MALIGNANT	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER METASTATIC	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER STAGE I	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BRONCHIOLOALVEOLAR CARCINOMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CANCER PAIN	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CARCINOID TUMOUR OF THE DUODENUM	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CARCINOID TUMOUR PULMONARY	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CARDIAC MYXOMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CENTRAL NERVOUS SYSTEM LYMPHOMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CEREBELLAR TUMOUR	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CERVIX CARCINOMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CHOLESTEATOMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CHRONIC LYMPHOCYTIC LEUKAEMIA	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CHRONIC MYELOID LEUKAEMIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON CANCER RECURRENT	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON CANCER STAGE II	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON NEOPLASM	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ESSENTIAL THROMBOCYTHAEMIA	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) FOLLICLE CENTRE LYMPHOMA, FOLLICULAR GRADE I, II, III	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) FOLLICLE CENTRE LYMPHOMA, FOLLICULAR GRADE I, II, III STAGE II	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GASTRIC ADENOMA	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GENITOURINARY TRACT NEOPLASM	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GLIOBLASTOMA MULTIFORME	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GLIOMA	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HAEMANGIOMA	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) INTESTINAL ADENOCARCINOMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LARGE CELL CARCINOMA OF THE RESPIRATORY TRACT STAGE UNSPECIFIED	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LARYNGEAL NEOPLASM	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LENTIGO MALIGNA STAGE UNSPECIFIED	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE IV	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG INFILTRATION MALIGNANT	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG SQUAMOUS CELL CARCINOMA METASTATIC	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG SQUAMOUS CELL CARCINOMA STAGE I	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG SQUAMOUS CELL CARCINOMA STAGE III	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LYMPHOCYTIC LYMPHOMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT ASCITES	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT MELANOMA IN SITU	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT MESENCHYMOMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT NEOPLASM OF AMPULLA OF VATER	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT NEOPLASM OF RENAL PELVIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT PERITONEAL NEOPLASM	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO GALLBLADDER	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO LARGE INTESTINE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO LUNG	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO PERITONEUM	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO SPINE	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTATIC LYMPHOMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTATIC NEOPLASM	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MULTIPLE MYELOMA	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NASAL CAVITY CANCER	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NASOPHARYNGEAL CANCER	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEOPLASM	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEOPLASM SKIN	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEUROENDOCRINE CARCINOMA OF THE SKIN	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NON-SMALL CELL LUNG CANCER METASTATIC	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OVARIAN ADENOMA	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PENIS CARCINOMA RECURRENT	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RECTAL NEOPLASM	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) REFRACTORY CYTOPENIA WITH MULTILINEAGE DYSPLASIA	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL CANCER METASTATIC	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL CANCER STAGE II	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL NEOPLASM	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL ONCOCYTOMA	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RETROPERITONEAL CANCER	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SALIVARY GLAND ADENOMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SARCOMA	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SARCOMA OF SKIN	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SMALL CELL CARCINOMA	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SPINAL HAEMANGIOMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TESTIS CANCER	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TONSIL CANCER	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) UNDIFFERENTIATED SARCOMA	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) URETERAL NEOPLASM	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) URETHRAL CANCER METASTATIC	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) UTERINE LEIOMYOSARCOMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) VULVAL CANCER	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) VULVAL CANCER METASTATIC	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) VULVAL CANCER RECURRENT	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Blood and lymphatic system disorders ANAEMIA	0.88% 62/7012 • Number of events 74 • On treatment (safety analysis set)	1.3% 91/7012 • Number of events 106 • On treatment (safety analysis set)	1.00% 70/7002 • Number of events 77 • On treatment (safety analysis set)
Blood and lymphatic system disorders IRON DEFICIENCY ANAEMIA	0.19% 13/7012 • Number of events 14 • On treatment (safety analysis set)	0.48% 34/7012 • Number of events 37 • On treatment (safety analysis set)	0.20% 14/7002 • Number of events 15 • On treatment (safety analysis set)
Blood and lymphatic system disorders SPONTANEOUS HAEMATOMA	0.31% 22/7012 • Number of events 23 • On treatment (safety analysis set)	0.14% 10/7012 • Number of events 10 • On treatment (safety analysis set)	0.07% 5/7002 • Number of events 5 • On treatment (safety analysis set)
Blood and lymphatic system disorders HYPOCHROMIC ANAEMIA	0.00% 0/7012 • On treatment (safety analysis set)	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Blood and lymphatic system disorders HAEMORRHAGIC ANAEMIA	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.11% 8/7002 • Number of events 8 • On treatment (safety analysis set)
Blood and lymphatic system disorders NORMOCHROMIC NORMOCYTIC ANAEMIA	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 13 • On treatment (safety analysis set)
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 2 • On treatment (safety analysis set)
Blood and lymphatic system disorders LEUKOCYTOSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Blood and lymphatic system disorders LYMPHADENITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Blood and lymphatic system disorders LYMPHADENOPATHY	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Blood and lymphatic system disorders MICROCYTIC ANAEMIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Blood and lymphatic system disorders PANCYTOPENIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Blood and lymphatic system disorders ANAEMIA MEGALOBLASTIC	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Blood and lymphatic system disorders ANAEMIA OF CHRONIC DISEASE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Blood and lymphatic system disorders ANAEMIA VITAMIN B12 DEFICIENCY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Blood and lymphatic system disorders AUTOIMMUNE THROMBOCYTOPENIA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Blood and lymphatic system disorders COAGULOPATHY	0.13% 9/7012 • Number of events 10 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Blood and lymphatic system disorders DISSEMINATED INTRAVASCULAR COAGULATION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Blood and lymphatic system disorders HAEMOLYTIC ANAEMIA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Blood and lymphatic system disorders MACROCYTOSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Blood and lymphatic system disorders POLYCYTHAEMIA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Blood and lymphatic system disorders THROMBOCYTOSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Blood and lymphatic system disorders ANAEMIA FOLATE DEFICIENCY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Blood and lymphatic system disorders ANAEMIA MACROCYTIC	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Blood and lymphatic system disorders ANAEMIA OF MALIGNANT DISEASE	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Blood and lymphatic system disorders APLASTIC ANAEMIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Blood and lymphatic system disorders BONE MARROW FAILURE	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Blood and lymphatic system disorders HAEMORRHAGIC DIATHESIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Blood and lymphatic system disorders HEPARIN-INDUCED THROMBOCYTOPENIA	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Blood and lymphatic system disorders HYPERCOAGULATION	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Blood and lymphatic system disorders HYPOCOAGULABLE STATE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Blood and lymphatic system disorders IDIOPATHIC THROMBOCYTOPENIC PURPURA	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Blood and lymphatic system disorders LYMPHADENOPATHY MEDIASTINAL	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Blood and lymphatic system disorders NEPHROGENIC ANAEMIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Blood and lymphatic system disorders NEUTROPENIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Blood and lymphatic system disorders PERNICIOUS ANAEMIA	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Blood and lymphatic system disorders SPLENOMEGALY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Immune system disorders DRUG HYPERSENSITIVITY	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Immune system disorders HYPERSENSITIVITY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Immune system disorders ANAPHYLACTIC REACTION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Immune system disorders ANAPHYLACTIC SHOCK	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Immune system disorders SECONDARY IMMUNODEFICIENCY	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Immune system disorders ALLERGY TO ARTHROPOD BITE	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Immune system disorders AMYLOIDOSIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Immune system disorders SARCOIDOSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Endocrine disorders GOITRE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.09% 6/7002 • Number of events 6 • On treatment (safety analysis set)
Endocrine disorders HYPOTHYROIDISM	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Endocrine disorders HYPERTHYROIDISM	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 3 • On treatment (safety analysis set)	0.09% 6/7002 • Number of events 6 • On treatment (safety analysis set)
Endocrine disorders CARCINOID SYNDROME	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Endocrine disorders HYPERPARATHYROIDISM	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Endocrine disorders INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Endocrine disorders AUTOIMMUNE THYROIDITIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Endocrine disorders BASEDOW'S DISEASE	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Endocrine disorders HYPERPARATHYROIDISM PRIMARY	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Endocrine disorders MYXOEDEMA	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Endocrine disorders SECONDARY ADRENOCORTICAL INSUFFICIENCY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Endocrine disorders THYROIDITIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Metabolism and nutrition disorders DEHYDRATION	0.47% 33/7012 • Number of events 33 • On treatment (safety analysis set)	0.40% 28/7012 • Number of events 31 • On treatment (safety analysis set)	0.60% 42/7002 • Number of events 45 • On treatment (safety analysis set)
Metabolism and nutrition disorders HYPOGLYCAEMIA	0.23% 16/7012 • Number of events 18 • On treatment (safety analysis set)	0.34% 24/7012 • Number of events 24 • On treatment (safety analysis set)	0.23% 16/7002 • Number of events 17 • On treatment (safety analysis set)
Metabolism and nutrition disorders DIABETES MELLITUS	0.26% 18/7012 • Number of events 18 • On treatment (safety analysis set)	0.30% 21/7012 • Number of events 21 • On treatment (safety analysis set)	0.51% 36/7002 • Number of events 41 • On treatment (safety analysis set)
Metabolism and nutrition disorders HYPONATRAEMIA	0.23% 16/7012 • Number of events 17 • On treatment (safety analysis set)	0.21% 15/7012 • Number of events 15 • On treatment (safety analysis set)	0.19% 13/7002 • Number of events 13 • On treatment (safety analysis set)
Metabolism and nutrition disorders HYPERGLYCAEMIA	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.16% 11/7012 • Number of events 11 • On treatment (safety analysis set)	0.13% 9/7002 • Number of events 10 • On treatment (safety analysis set)
Metabolism and nutrition disorders DIABETES MELLITUS INADEQUATE CONTROL	0.10% 7/7012 • Number of events 7 • On treatment (safety analysis set)	0.14% 10/7012 • Number of events 10 • On treatment (safety analysis set)	0.21% 15/7002 • Number of events 18 • On treatment (safety analysis set)
Metabolism and nutrition disorders HYPERKALAEMIA	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.10% 7/7012 • Number of events 7 • On treatment (safety analysis set)	0.21% 15/7002 • Number of events 17 • On treatment (safety analysis set)
Metabolism and nutrition disorders HYPOKALAEMIA	0.16% 11/7012 • Number of events 11 • On treatment (safety analysis set)	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.11% 8/7002 • Number of events 10 • On treatment (safety analysis set)
Metabolism and nutrition disorders GOUT	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Metabolism and nutrition disorders TYPE 2 DIABETES MELLITUS	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.07% 5/7002 • Number of events 5 • On treatment (safety analysis set)
Metabolism and nutrition disorders DIABETIC FOOT	0.14% 10/7012 • Number of events 10 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 4 • On treatment (safety analysis set)
Metabolism and nutrition disorders HYPERCALCAEMIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Metabolism and nutrition disorders DECREASED APPETITE	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Metabolism and nutrition disorders DIABETIC KETOACIDOSIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Metabolism and nutrition disorders FAILURE TO THRIVE	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Metabolism and nutrition disorders FLUID OVERLOAD	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Metabolism and nutrition disorders MALNUTRITION	0.03% 2/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Metabolism and nutrition disorders METABOLIC ACIDOSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Metabolism and nutrition disorders CACHEXIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Metabolism and nutrition disorders HYPEROSMOLAR STATE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Metabolism and nutrition disorders HYPERVOLAEMIA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Metabolism and nutrition disorders HYPOVOLAEMIA	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Metabolism and nutrition disorders METABOLIC DISORDER	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Metabolism and nutrition disorders SHOCK HYPOGLYCAEMIC	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Metabolism and nutrition disorders CALCIPHYLAXIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Metabolism and nutrition disorders DYSLIPIDAEMIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Metabolism and nutrition disorders ELECTROLYTE IMBALANCE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Metabolism and nutrition disorders FOLATE DEFICIENCY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Metabolism and nutrition disorders HYPERNATRAEMIA	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Metabolism and nutrition disorders HYPERURICAEMIA	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Metabolism and nutrition disorders IRON DEFICIENCY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Metabolism and nutrition disorders LACTIC ACIDOSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Metabolism and nutrition disorders NEUROGLYCOPENIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Metabolism and nutrition disorders OBESITY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Metabolism and nutrition disorders VITAMIN B12 DEFICIENCY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 2 • On treatment (safety analysis set)
Psychiatric disorders MENTAL STATUS CHANGES	0.10% 7/7012 • Number of events 7 • On treatment (safety analysis set)	0.17% 12/7012 • Number of events 13 • On treatment (safety analysis set)	0.11% 8/7002 • Number of events 8 • On treatment (safety analysis set)
Psychiatric disorders DEPRESSION	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.16% 11/7012 • Number of events 12 • On treatment (safety analysis set)	0.17% 12/7002 • Number of events 12 • On treatment (safety analysis set)
Psychiatric disorders ANXIETY	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.11% 8/7012 • Number of events 9 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Psychiatric disorders DELIRIUM	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.11% 8/7012 • Number of events 9 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 5 • On treatment (safety analysis set)
Psychiatric disorders CONFUSIONAL STATE	0.09% 6/7012 • Number of events 7 • On treatment (safety analysis set)	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.07% 5/7002 • Number of events 5 • On treatment (safety analysis set)
Psychiatric disorders ALCOHOL ABUSE	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Psychiatric disorders COMPLETED SUICIDE	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Psychiatric disorders PSYCHOTIC DISORDER	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Psychiatric disorders ANXIETY DISORDER	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Psychiatric disorders SUICIDE ATTEMPT	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Psychiatric disorders AGITATION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Psychiatric disorders ALCOHOLISM	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Psychiatric disorders DEPRESSED MOOD	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders DYSARTHRIA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Psychiatric disorders EMOTIONAL DISTRESS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Psychiatric disorders HALLUCINATION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Psychiatric disorders INTENTIONAL SELF-INJURY	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Psychiatric disorders MENTAL DISORDER	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Psychiatric disorders SUICIDAL IDEATION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Psychiatric disorders ACUTE PSYCHOSIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Psychiatric disorders ACUTE STRESS DISORDER	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Psychiatric disorders AGGRESSION	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Psychiatric disorders BIPOLAR DISORDER	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Psychiatric disorders BURNOUT SYNDROME	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Psychiatric disorders DELIRIUM TREMENS	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Psychiatric disorders DEPRESSION SUICIDAL	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Psychiatric disorders DISORIENTATION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Psychiatric disorders DRUG ABUSE	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Psychiatric disorders DRUG DEPENDENCE	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Psychiatric disorders DYSPHORIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Psychiatric disorders GENERALISED ANXIETY DISORDER	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Psychiatric disorders MAJOR DEPRESSION	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Psychiatric disorders MENTAL DISORDER DUE TO A GENERAL MEDICAL CONDITION	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Psychiatric disorders PANIC ATTACK	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Psychiatric disorders PANIC DISORDER	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Psychiatric disorders PSYCHOSOMATIC DISEASE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Psychiatric disorders SCHIZOPHRENIA	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders CEREBROVASCULAR ACCIDENT	1.3% 88/7012 • Number of events 94 • On treatment (safety analysis set)	1.5% 104/7012 • Number of events 111 • On treatment (safety analysis set)	1.8% 125/7002 • Number of events 138 • On treatment (safety analysis set)
Nervous system disorders TRANSIENT ISCHAEMIC ATTACK	1.1% 74/7012 • Number of events 81 • On treatment (safety analysis set)	1.2% 85/7012 • Number of events 97 • On treatment (safety analysis set)	1.5% 107/7002 • Number of events 125 • On treatment (safety analysis set)
Nervous system disorders ISCHAEMIC STROKE	1.4% 95/7012 • Number of events 105 • On treatment (safety analysis set)	1.2% 83/7012 • Number of events 85 • On treatment (safety analysis set)	2.0% 141/7002 • Number of events 152 • On treatment (safety analysis set)
Nervous system disorders SYNCOPE	0.93% 65/7012 • Number of events 68 • On treatment (safety analysis set)	0.76% 53/7012 • Number of events 55 • On treatment (safety analysis set)	0.91% 64/7002 • Number of events 65 • On treatment (safety analysis set)
Nervous system disorders CEREBRAL INFARCTION	0.30% 21/7012 • Number of events 22 • On treatment (safety analysis set)	0.43% 30/7012 • Number of events 33 • On treatment (safety analysis set)	0.64% 45/7002 • Number of events 51 • On treatment (safety analysis set)
Nervous system disorders CEREBRAL HAEMORRHAGE	0.46% 32/7012 • Number of events 33 • On treatment (safety analysis set)	0.33% 23/7012 • Number of events 23 • On treatment (safety analysis set)	0.16% 11/7002 • Number of events 11 • On treatment (safety analysis set)
Nervous system disorders DIZZINESS	0.17% 12/7012 • Number of events 13 • On treatment (safety analysis set)	0.21% 15/7012 • Number of events 15 • On treatment (safety analysis set)	0.21% 15/7002 • Number of events 17 • On treatment (safety analysis set)
Nervous system disorders HAEMORRHAGE INTRACRANIAL	0.51% 36/7012 • Number of events 37 • On treatment (safety analysis set)	0.19% 13/7012 • Number of events 14 • On treatment (safety analysis set)	0.17% 12/7002 • Number of events 12 • On treatment (safety analysis set)
Nervous system disorders CAROTID ARTERY STENOSIS	0.19% 13/7012 • Number of events 13 • On treatment (safety analysis set)	0.17% 12/7012 • Number of events 12 • On treatment (safety analysis set)	0.17% 12/7002 • Number of events 12 • On treatment (safety analysis set)
Nervous system disorders PRESYNCOPE	0.14% 10/7012 • Number of events 10 • On treatment (safety analysis set)	0.17% 12/7012 • Number of events 12 • On treatment (safety analysis set)	0.21% 15/7002 • Number of events 15 • On treatment (safety analysis set)
Nervous system disorders CONVULSION	0.17% 12/7012 • Number of events 12 • On treatment (safety analysis set)	0.16% 11/7012 • Number of events 12 • On treatment (safety analysis set)	0.17% 12/7002 • Number of events 14 • On treatment (safety analysis set)
Nervous system disorders SUBARACHNOID HAEMORRHAGE	0.24% 17/7012 • Number of events 17 • On treatment (safety analysis set)	0.16% 11/7012 • Number of events 13 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Nervous system disorders DEMENTIA	0.14% 10/7012 • Number of events 10 • On treatment (safety analysis set)	0.11% 8/7012 • Number of events 8 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders HAEMORRHAGIC STROKE	0.29% 20/7012 • Number of events 22 • On treatment (safety analysis set)	0.11% 8/7012 • Number of events 8 • On treatment (safety analysis set)	0.09% 6/7002 • Number of events 7 • On treatment (safety analysis set)
Nervous system disorders GRAND MAL CONVULSION	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.07% 5/7002 • Number of events 5 • On treatment (safety analysis set)
Nervous system disorders VERTEBROBASILAR INSUFFICIENCY	0.14% 10/7012 • Number of events 12 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 6 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 5 • On treatment (safety analysis set)
Nervous system disorders CEREBRAL ISCHAEMIA	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 5 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Nervous system disorders EMBOLIC STROKE	0.11% 8/7012 • Number of events 9 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.07% 5/7002 • Number of events 5 • On treatment (safety analysis set)
Nervous system disorders EPILEPSY	0.20% 14/7012 • Number of events 16 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 10 • On treatment (safety analysis set)	0.20% 14/7002 • Number of events 15 • On treatment (safety analysis set)
Nervous system disorders HEADACHE	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Nervous system disorders HEMIPARESIS	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders LOSS OF CONSCIOUSNESS	0.10% 7/7012 • Number of events 7 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders VASCULAR ENCEPHALOPATHY	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 5 • On treatment (safety analysis set)	0.07% 5/7002 • Number of events 5 • On treatment (safety analysis set)
Nervous system disorders BRAIN STEM INFARCTION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders COMPLEX PARTIAL SEIZURES	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Nervous system disorders DEMENTIA ALZHEIMER'S TYPE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders HYPOXIC-ISCHAEMIC ENCEPHALOPATHY	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Nervous system disorders LACUNAR INFARCTION	0.10% 7/7012 • Number of events 7 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.09% 6/7002 • Number of events 8 • On treatment (safety analysis set)
Nervous system disorders RADICULOPATHY	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 2 • On treatment (safety analysis set)
Nervous system disorders THALAMUS HAEMORRHAGE	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Nervous system disorders AMNESIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders BRAIN STEM HAEMORRHAGE	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders BRAIN STEM STROKE	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders CAROTID ARTERY DISEASE	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders CEREBELLAR HAEMORRHAGE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders CEREBELLAR INFARCTION	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Nervous system disorders CEREBRAL ARTERIOSCLEROSIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Nervous system disorders CEREBROVASCULAR DISORDER	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Nervous system disorders DIABETIC NEUROPATHY	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders ENCEPHALOPATHY	0.07% 5/7012 • Number of events 7 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Nervous system disorders INTERCOSTAL NEURALGIA	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders METABOLIC ENCEPHALOPATHY	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders PARKINSONISM	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Nervous system disorders PERIPHERAL SENSORIMOTOR NEUROPATHY	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders SCIATICA	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Nervous system disorders THROMBOTIC CEREBRAL INFARCTION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders TRANSIENT GLOBAL AMNESIA	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders VIITH NERVE PARALYSIS	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Nervous system disorders AMNESTIC DISORDER	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders AMYOTROPHIC LATERAL SCLEROSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders APHASIA	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders ASTERIXIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders ATAXIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders BASILAR ARTERY THROMBOSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders BRAIN INJURY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Nervous system disorders BRAIN MASS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders BRAIN STEM ISCHAEMIA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders CAROTID ARTERY OCCLUSION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders CAROTID SINUS SYNDROME	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders CARPAL TUNNEL SYNDROME	0.04% 3/7012 • Number of events 4 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Nervous system disorders CENTRAL NERVOUS SYSTEM LESION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders CEREBELLAR ATAXIA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders CEREBRAL ARTERY OCCLUSION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders CEREBRAL ATROPHY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders CEREBRAL CIRCULATORY FAILURE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Nervous system disorders CEREBRAL HAEMATOMA	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders CERVICOBRACHIAL SYNDROME	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders CLUSTER HEADACHE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders COGNITIVE DISORDER	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders COMA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Nervous system disorders COMA HEPATIC	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders DRUG WITHDRAWAL CONVULSIONS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders ENCEPHALOMALACIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders FACIAL PARESIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders HEPATIC ENCEPHALOPATHY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders HYPERTENSIVE ENCEPHALOPATHY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Nervous system disorders NERVE COMPRESSION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders HYPOAESTHESIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders HYPOGLYCAEMIC COMA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders MIGRAINE WITH AURA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders MONONEUROPATHY MULTIPLEX	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders MOTOR NEURONE DISEASE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders MYELOPATHY	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders NARCOLEPSY	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders NEURALGIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders NEURITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders NEUROPATHY PERIPHERAL	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders PARKINSON'S DISEASE	0.04% 3/7012 • Number of events 4 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 4 • On treatment (safety analysis set)
Nervous system disorders PARTIAL SEIZURES	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders PARTIAL SEIZURES WITH SECONDARY GENERALISATION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders PUTAMEN HAEMORRHAGE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders RADICULAR PAIN	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders RADICULAR SYNDROME	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders RADICULITIS LUMBOSACRAL	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders SOMNOLENCE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders SPINAL CORD DISORDER	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders THROMBOTIC STROKE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders TRIGEMINAL NEURALGIA	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders ULNAR NERVE PALSY	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders UNRESPONSIVE TO STIMULI	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders AKINESIA	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders ALCOHOL INDUCED PERSISTING DEMENTIA	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders ALTERED STATE OF CONSCIOUSNESS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders BALANCE DISORDER	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders BASAL GANGLIA HAEMORRHAGE	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders BRACHIAL PLEXOPATHY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders BRAIN OEDEMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Nervous system disorders CAROTID ARTERIOSCLEROSIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders CAROTID ARTERY THROMBOSIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders CAUDA EQUINA SYNDROME	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders CEREBELLAR ISCHAEMIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders CEREBELLAR SYNDROME	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Nervous system disorders CEREBRAL AMYLOID ANGIOPATHY	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders CEREBRAL ARTERY EMBOLISM	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Nervous system disorders CEREBRAL HYPOPERFUSION	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Nervous system disorders CEREBRAL THROMBOSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders CEREBROVASCULAR INSUFFICIENCY	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Nervous system disorders CERVICAL CORD COMPRESSION	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders CERVICAL MYELOPATHY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders CRITICAL ILLNESS POLYNEUROPATHY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders CUBITAL TUNNEL SYNDROME	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders DEMENTIA WITH LEWY BODIES	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders DEMYELINATING POLYNEUROPATHY	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders DEPRESSED LEVEL OF CONSCIOUSNESS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders EMBOLIC CEREBRAL INFARCTION	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders ENCEPHALITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders ESSENTIAL TREMOR	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders GUILLAIN-BARRE SYNDROME	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders HAEMORRHAGIC CEREBRAL INFARCTION	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Nervous system disorders HAEMORRHAGIC TRANSFORMATION STROKE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders HYDROCEPHALUS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Nervous system disorders HYPERCAPNIC ENCEPHALOPATHY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders HYPOKINESIA	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders HYPONATRAEMIC ENCEPHALOPATHY	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders IIIRD NERVE PARALYSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders INTRACRANIAL ANEURYSM	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders INTRACRANIAL HAEMATOMA	0.01% 1/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders INTRAVENTRICULAR HAEMORRHAGE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Nervous system disorders ISCHAEMIC CEREBRAL INFARCTION	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.07% 5/7002 • Number of events 5 • On treatment (safety analysis set)
Nervous system disorders ISCHAEMIC NEUROPATHY	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders LATERAL MEDULLARY SYNDROME	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders LUMBAR RADICULOPATHY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders MIGRAINE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Nervous system disorders MONOPARESIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders MYASTHENIA GRAVIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders NEUROLOGICAL SYMPTOM	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders NEUROMYOPATHY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders NORMAL PRESSURE HYDROCEPHALUS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders OPTIC NEURITIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders ORTHOSTATIC INTOLERANCE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders PARAESTHESIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders PARAPLEGIA	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders PHRENIC NERVE PARALYSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders POLYNEUROPATHY	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Nervous system disorders POST-TRAUMATIC EPILEPSY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders REVERSIBLE ISCHAEMIC NEUROLOGICAL DEFICIT	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders SENILE DEMENTIA	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders SIMPLE PARTIAL SEIZURES	0.01% 1/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders SPEECH DISORDER	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Nervous system disorders SPINAL HAEMATOMA	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders STATUS EPILEPTICUS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 3 • On treatment (safety analysis set)
Nervous system disorders SUBDURAL HYGROMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders TENSION HEADACHE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Nervous system disorders TREMOR	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Nervous system disorders VOCAL CORD PARALYSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Eye disorders CATARACT	0.67% 47/7012 • Number of events 63 • On treatment (safety analysis set)	0.83% 58/7012 • Number of events 65 • On treatment (safety analysis set)	0.86% 60/7002 • Number of events 72 • On treatment (safety analysis set)
Eye disorders GLAUCOMA	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 5 • On treatment (safety analysis set)
Eye disorders VITREOUS HAEMORRHAGE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Eye disorders AGE-RELATED MACULAR DEGENERATION	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Eye disorders OPTIC ISCHAEMIC NEUROPATHY	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Eye disorders RETINAL DETACHMENT	0.04% 3/7012 • Number of events 4 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.07% 5/7002 • Number of events 7 • On treatment (safety analysis set)
Eye disorders RETINAL VEIN OCCLUSION	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Eye disorders AMAUROSIS FUGAX	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 2 • On treatment (safety analysis set)
Eye disorders ANGLE CLOSURE GLAUCOMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Eye disorders BLINDNESS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Eye disorders CATARACT NUCLEAR	0.01% 1/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Eye disorders CONJUNCTIVAL HAEMORRHAGE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Eye disorders CORNEAL DEGENERATION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Eye disorders ENTROPION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Eye disorders EYE HAEMORRHAGE	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Eye disorders MACULAR OEDEMA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Eye disorders RETINAL ARTERY EMBOLISM	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Eye disorders RETINAL ARTERY OCCLUSION	0.01% 1/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Eye disorders RETINAL HAEMORRHAGE	0.09% 6/7012 • Number of events 7 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Eye disorders RETINOPATHY	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Eye disorders SCOTOMA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Eye disorders AMBLYOPIA	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Eye disorders APHAKIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Eye disorders ARTERIOSCLEROTIC RETINOPATHY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Eye disorders CHOROIDAL HAEMORRHAGE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Eye disorders CONJUNCTIVITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Eye disorders CORNEAL DECOMPENSATION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Eye disorders DIABETIC RETINOPATHY	0.07% 5/7012 • Number of events 6 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 2 • On treatment (safety analysis set)
Eye disorders DIPLOPIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Eye disorders EYELID PTOSIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Eye disorders FUCHS' SYNDROME	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Eye disorders KERATOPATHY	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Eye disorders LACRIMATION INCREASED	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Eye disorders LENS DISLOCATION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Eye disorders MACULAR DEGENERATION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Eye disorders MACULAR FIBROSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 3 • On treatment (safety analysis set)
Eye disorders MACULAR HOLE	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Eye disorders MACULOPATHY	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Eye disorders OPEN ANGLE GLAUCOMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Eye disorders PANOPHTHALMITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Eye disorders PAPILLOEDEMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Eye disorders PTERYGIUM	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Eye disorders RETINAL ARTERY THROMBOSIS	0.03% 2/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 2 • On treatment (safety analysis set)
Eye disorders RETINAL VASCULAR THROMBOSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Eye disorders RETINAL VEIN THROMBOSIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Eye disorders SCLERAL HAEMORRHAGE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Eye disorders SCLERITIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Eye disorders STRABISMUS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Eye disorders ULCERATIVE KERATITIS	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Eye disorders VISUAL IMPAIRMENT	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Ear and labyrinth disorders VERTIGO	0.16% 11/7012 • Number of events 11 • On treatment (safety analysis set)	0.21% 15/7012 • Number of events 16 • On treatment (safety analysis set)	0.21% 15/7002 • Number of events 17 • On treatment (safety analysis set)
Ear and labyrinth disorders VERTIGO POSITIONAL	0.10% 7/7012 • Number of events 9 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 6 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 5 • On treatment (safety analysis set)
Ear and labyrinth disorders VESTIBULAR DISORDER	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Ear and labyrinth disorders HYPOACUSIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Ear and labyrinth disorders MENIERE'S DISEASE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Ear and labyrinth disorders TYMPANIC MEMBRANE PERFORATION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Ear and labyrinth disorders DEAFNESS NEUROSENSORY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Ear and labyrinth disorders DEAFNESS UNILATERAL	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Ear and labyrinth disorders SUDDEN HEARING LOSS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Cardiac disorders CARDIAC FAILURE	5.3% 371/7012 • Number of events 534 • On treatment (safety analysis set)	4.5% 318/7012 • Number of events 458 • On treatment (safety analysis set)	4.3% 300/7002 • Number of events 418 • On treatment (safety analysis set)
Cardiac disorders ATRIAL FIBRILLATION	4.9% 343/7012 • Number of events 495 • On treatment (safety analysis set)	4.5% 315/7012 • Number of events 466 • On treatment (safety analysis set)	5.2% 367/7002 • Number of events 534 • On treatment (safety analysis set)
Cardiac disorders CARDIAC FAILURE CONGESTIVE	4.2% 291/7012 • Number of events 406 • On treatment (safety analysis set)	4.2% 291/7012 • Number of events 421 • On treatment (safety analysis set)	3.9% 270/7002 • Number of events 374 • On treatment (safety analysis set)
Cardiac disorders MYOCARDIAL INFARCTION	2.0% 142/7012 • Number of events 154 • On treatment (safety analysis set)	2.1% 147/7012 • Number of events 164 • On treatment (safety analysis set)	2.7% 189/7002 • Number of events 204 • On treatment (safety analysis set)
Cardiac disorders ANGINA UNSTABLE	2.0% 137/7012 • Number of events 154 • On treatment (safety analysis set)	1.8% 127/7012 • Number of events 141 • On treatment (safety analysis set)	1.7% 120/7002 • Number of events 146 • On treatment (safety analysis set)
Cardiac disorders ANGINA PECTORIS	1.1% 80/7012 • Number of events 88 • On treatment (safety analysis set)	0.87% 61/7012 • Number of events 64 • On treatment (safety analysis set)	1.1% 77/7002 • Number of events 80 • On treatment (safety analysis set)
Cardiac disorders SICK SINUS SYNDROME	0.96% 67/7012 • Number of events 68 • On treatment (safety analysis set)	0.71% 50/7012 • Number of events 51 • On treatment (safety analysis set)	0.91% 64/7002 • Number of events 65 • On treatment (safety analysis set)
Cardiac disorders BRADYCARDIA	0.80% 56/7012 • Number of events 58 • On treatment (safety analysis set)	0.63% 44/7012 • Number of events 47 • On treatment (safety analysis set)	0.57% 40/7002 • Number of events 41 • On treatment (safety analysis set)
Cardiac disorders CARDIAC FAILURE CHRONIC	0.54% 38/7012 • Number of events 41 • On treatment (safety analysis set)	0.63% 44/7012 • Number of events 55 • On treatment (safety analysis set)	0.66% 46/7002 • Number of events 65 • On treatment (safety analysis set)
Cardiac disorders ATRIAL FLUTTER	0.66% 46/7012 • Number of events 62 • On treatment (safety analysis set)	0.50% 35/7012 • Number of events 44 • On treatment (safety analysis set)	0.59% 41/7002 • Number of events 48 • On treatment (safety analysis set)
Cardiac disorders VENTRICULAR TACHYCARDIA	0.58% 41/7012 • Number of events 44 • On treatment (safety analysis set)	0.47% 33/7012 • Number of events 38 • On treatment (safety analysis set)	0.56% 39/7002 • Number of events 47 • On treatment (safety analysis set)
Cardiac disorders CARDIAC ARREST	0.37% 26/7012 • Number of events 27 • On treatment (safety analysis set)	0.39% 27/7012 • Number of events 27 • On treatment (safety analysis set)	0.30% 21/7002 • Number of events 23 • On treatment (safety analysis set)
Cardiac disorders CARDIAC FAILURE ACUTE	0.40% 28/7012 • Number of events 31 • On treatment (safety analysis set)	0.39% 27/7012 • Number of events 29 • On treatment (safety analysis set)	0.33% 23/7002 • Number of events 27 • On treatment (safety analysis set)
Cardiac disorders CORONARY ARTERY DISEASE	0.51% 36/7012 • Number of events 38 • On treatment (safety analysis set)	0.39% 27/7012 • Number of events 30 • On treatment (safety analysis set)	0.39% 27/7002 • Number of events 27 • On treatment (safety analysis set)
Cardiac disorders CARDIO-RESPIRATORY ARREST	0.31% 22/7012 • Number of events 22 • On treatment (safety analysis set)	0.33% 23/7012 • Number of events 23 • On treatment (safety analysis set)	0.26% 18/7002 • Number of events 18 • On treatment (safety analysis set)
Cardiac disorders ARRHYTHMIA	0.19% 13/7012 • Number of events 13 • On treatment (safety analysis set)	0.23% 16/7012 • Number of events 17 • On treatment (safety analysis set)	0.19% 13/7002 • Number of events 14 • On treatment (safety analysis set)
Cardiac disorders CARDIOMYOPATHY	0.13% 9/7012 • Number of events 9 • On treatment (safety analysis set)	0.19% 13/7012 • Number of events 13 • On treatment (safety analysis set)	0.10% 7/7002 • Number of events 11 • On treatment (safety analysis set)
Cardiac disorders CARDIOGENIC SHOCK	0.21% 15/7012 • Number of events 15 • On treatment (safety analysis set)	0.17% 12/7012 • Number of events 12 • On treatment (safety analysis set)	0.26% 18/7002 • Number of events 18 • On treatment (safety analysis set)
Cardiac disorders BRADYARRHYTHMIA	0.14% 10/7012 • Number of events 10 • On treatment (safety analysis set)	0.16% 11/7012 • Number of events 11 • On treatment (safety analysis set)	0.14% 10/7002 • Number of events 10 • On treatment (safety analysis set)
Cardiac disorders MYOCARDIAL ISCHAEMIA	0.09% 6/7012 • Number of events 8 • On treatment (safety analysis set)	0.16% 11/7012 • Number of events 11 • On treatment (safety analysis set)	0.17% 12/7002 • Number of events 13 • On treatment (safety analysis set)
Cardiac disorders ATRIOVENTRICULAR BLOCK	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.14% 10/7012 • Number of events 11 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Cardiac disorders LEFT VENTRICULAR FAILURE	0.06% 4/7012 • Number of events 6 • On treatment (safety analysis set)	0.14% 10/7012 • Number of events 12 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Cardiac disorders SUPRAVENTRICULAR TACHYCARDIA	0.10% 7/7012 • Number of events 8 • On treatment (safety analysis set)	0.14% 10/7012 • Number of events 13 • On treatment (safety analysis set)	0.10% 7/7002 • Number of events 10 • On treatment (safety analysis set)
Cardiac disorders MITRAL VALVE INCOMPETENCE	0.20% 14/7012 • Number of events 14 • On treatment (safety analysis set)	0.13% 9/7012 • Number of events 9 • On treatment (safety analysis set)	0.24% 17/7002 • Number of events 19 • On treatment (safety analysis set)
Cardiac disorders VENTRICULAR FIBRILLATION	0.16% 11/7012 • Number of events 11 • On treatment (safety analysis set)	0.13% 9/7012 • Number of events 11 • On treatment (safety analysis set)	0.10% 7/7002 • Number of events 7 • On treatment (safety analysis set)
Cardiac disorders ACUTE LEFT VENTRICULAR FAILURE	0.06% 4/7012 • Number of events 5 • On treatment (safety analysis set)	0.11% 8/7012 • Number of events 8 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 5 • On treatment (safety analysis set)
Cardiac disorders CONGESTIVE CARDIOMYOPATHY	0.14% 10/7012 • Number of events 13 • On treatment (safety analysis set)	0.10% 7/7012 • Number of events 7 • On treatment (safety analysis set)	0.17% 12/7002 • Number of events 13 • On treatment (safety analysis set)
Cardiac disorders CORONARY ARTERY STENOSIS	0.07% 5/7012 • Number of events 7 • On treatment (safety analysis set)	0.09% 6/7012 • Number of events 7 • On treatment (safety analysis set)	0.07% 5/7002 • Number of events 5 • On treatment (safety analysis set)
Cardiac disorders PALPITATIONS	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Cardiac disorders SINUS BRADYCARDIA	0.13% 9/7012 • Number of events 9 • On treatment (safety analysis set)	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.09% 6/7002 • Number of events 6 • On treatment (safety analysis set)
Cardiac disorders TACHYARRHYTHMIA	0.11% 8/7012 • Number of events 9 • On treatment (safety analysis set)	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.21% 15/7002 • Number of events 19 • On treatment (safety analysis set)
Cardiac disorders AORTIC VALVE STENOSIS	0.07% 5/7012 • Number of events 6 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.09% 6/7002 • Number of events 6 • On treatment (safety analysis set)
Cardiac disorders ATRIAL THROMBOSIS	0.10% 7/7012 • Number of events 7 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.10% 7/7002 • Number of events 7 • On treatment (safety analysis set)
Cardiac disorders PERICARDIAL EFFUSION	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 6 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Cardiac disorders ACUTE CORONARY SYNDROME	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 5 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Cardiac disorders ATRIAL TACHYCARDIA	0.10% 7/7012 • Number of events 8 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 5 • On treatment (safety analysis set)	0.09% 6/7002 • Number of events 9 • On treatment (safety analysis set)
Cardiac disorders ATRIOVENTRICULAR BLOCK COMPLETE	0.17% 12/7012 • Number of events 12 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.31% 22/7002 • Number of events 23 • On treatment (safety analysis set)
Cardiac disorders ATRIOVENTRICULAR BLOCK SECOND DEGREE	0.00% 0/7012 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Cardiac disorders CARDIOPULMONARY FAILURE	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.11% 8/7002 • Number of events 9 • On treatment (safety analysis set)
Cardiac disorders CORONARY ARTERY INSUFFICIENCY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Cardiac disorders ISCHAEMIC CARDIOMYOPATHY	0.10% 7/7012 • Number of events 8 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Cardiac disorders MYOCARDIAL FIBROSIS	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Cardiac disorders RIGHT VENTRICULAR FAILURE	0.10% 7/7012 • Number of events 9 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Cardiac disorders ADAMS-STOKES SYNDROME	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Cardiac disorders ARTERIOSCLEROSIS CORONARY ARTERY	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Cardiac disorders PERICARDIAL HAEMORRHAGE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Cardiac disorders VENTRICULAR ARRHYTHMIA	0.10% 7/7012 • Number of events 7 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Cardiac disorders AORTIC VALVE DISEASE	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Cardiac disorders AORTIC VALVE INCOMPETENCE	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Cardiac disorders CARDIAC VALVE DISEASE	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 4 • On treatment (safety analysis set)
Cardiac disorders CARDIOVASCULAR INSUFFICIENCY	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Cardiac disorders HEART VALVE INCOMPETENCE	0.06% 4/7012 • Number of events 5 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Cardiac disorders HYPERTROPHIC CARDIOMYOPATHY	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Cardiac disorders STRESS CARDIOMYOPATHY	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Cardiac disorders SUPRAVENTRICULAR TACHYARRHYTHMIA	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Cardiac disorders TACHYCARDIA	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.07% 5/7002 • Number of events 5 • On treatment (safety analysis set)
Cardiac disorders TRICUSPID VALVE INCOMPETENCE	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Cardiac disorders VENTRICULAR EXTRASYSTOLES	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Cardiac disorders AORTIC VALVE CALCIFICATION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Cardiac disorders ATRIOVENTRICULAR BLOCK FIRST DEGREE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Cardiac disorders BIFASCICULAR BLOCK	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Cardiac disorders BUNDLE BRANCH BLOCK LEFT	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Cardiac disorders CARDIAC ASTHMA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Cardiac disorders CARDIORENAL SYNDROME	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Cardiac disorders CARDIOVASCULAR DISORDER	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Cardiac disorders CHORDAE TENDINAE RUPTURE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Cardiac disorders CHRONOTROPIC INCOMPETENCE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Cardiac disorders CONDUCTION DISORDER	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Cardiac disorders CORONARY ARTERY ANEURYSM	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Cardiac disorders CORONARY ARTERY OCCLUSION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Cardiac disorders DRESSLER'S SYNDROME	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Cardiac disorders HYPERTENSIVE HEART DISEASE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Cardiac disorders LEFT VENTRICULAR DYSFUNCTION	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Cardiac disorders MITRAL VALVE DISEASE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Cardiac disorders MITRAL VALVE STENOSIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Cardiac disorders PULSELESS ELECTRICAL ACTIVITY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Cardiac disorders RHEUMATIC HEART DISEASE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Cardiac disorders SUPRAVENTRICULAR EXTRASYSTOLES	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Cardiac disorders VENTRICULAR TACHYARRHYTHMIA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Cardiac disorders AORTIC VALVE DISEASE MIXED	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Cardiac disorders ARRHYTHMIA SUPRAVENTRICULAR	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Cardiac disorders BUNDLE BRANCH BLOCK RIGHT	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Cardiac disorders CARDIAC FIBRILLATION	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Cardiac disorders CARDIAC TAMPONADE	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Cardiac disorders COR PULMONALE ACUTE	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 4 • On treatment (safety analysis set)
Cardiac disorders CORONARY ARTERY EMBOLISM	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Cardiac disorders CORONARY ARTERY THROMBOSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Cardiac disorders CYTOTOXIC CARDIOMYOPATHY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Cardiac disorders DIASTOLIC DYSFUNCTION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Cardiac disorders ENDOCARDITIS NONINFECTIVE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Cardiac disorders METABOLIC CARDIOMYOPATHY	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Cardiac disorders MITRAL VALVE PROLAPSE	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Cardiac disorders NODAL ARRHYTHMIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Cardiac disorders PRINZMETAL ANGINA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Cardiac disorders RHYTHM IDIOVENTRICULAR	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Cardiac disorders SINUS ARREST	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Cardiac disorders SINUS ARRHYTHMIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Cardiac disorders SYSTOLIC DYSFUNCTION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Cardiac disorders TACHYCARDIA PAROXYSMAL	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Cardiac disorders TORSADE DE POINTES	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Cardiac disorders TRIFASCICULAR BLOCK	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Cardiac disorders VENTRICULAR DYSFUNCTION	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Cardiac disorders WOLFF-PARKINSON-WHITE SYNDROME	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Vascular disorders HYPERTENSION	0.41% 29/7012 • Number of events 32 • On treatment (safety analysis set)	0.60% 42/7012 • Number of events 46 • On treatment (safety analysis set)	0.51% 36/7002 • Number of events 38 • On treatment (safety analysis set)
Vascular disorders HYPOTENSION	0.33% 23/7012 • Number of events 23 • On treatment (safety analysis set)	0.34% 24/7012 • Number of events 25 • On treatment (safety analysis set)	0.43% 30/7002 • Number of events 30 • On treatment (safety analysis set)
Vascular disorders DEEP VEIN THROMBOSIS	0.29% 20/7012 • Number of events 21 • On treatment (safety analysis set)	0.24% 17/7012 • Number of events 18 • On treatment (safety analysis set)	0.16% 11/7002 • Number of events 13 • On treatment (safety analysis set)
Vascular disorders HYPERTENSIVE CRISIS	0.21% 15/7012 • Number of events 15 • On treatment (safety analysis set)	0.23% 16/7012 • Number of events 16 • On treatment (safety analysis set)	0.19% 13/7002 • Number of events 14 • On treatment (safety analysis set)
Vascular disorders AORTIC ANEURYSM	0.17% 12/7012 • Number of events 12 • On treatment (safety analysis set)	0.13% 9/7012 • Number of events 9 • On treatment (safety analysis set)	0.20% 14/7002 • Number of events 15 • On treatment (safety analysis set)
Vascular disorders PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	0.16% 11/7012 • Number of events 12 • On treatment (safety analysis set)	0.13% 9/7012 • Number of events 9 • On treatment (safety analysis set)	0.34% 24/7002 • Number of events 28 • On treatment (safety analysis set)
Vascular disorders PERIPHERAL ISCHAEMIA	0.07% 5/7012 • Number of events 6 • On treatment (safety analysis set)	0.13% 9/7012 • Number of events 10 • On treatment (safety analysis set)	0.19% 13/7002 • Number of events 15 • On treatment (safety analysis set)
Vascular disorders AORTIC STENOSIS	0.21% 15/7012 • Number of events 15 • On treatment (safety analysis set)	0.11% 8/7012 • Number of events 8 • On treatment (safety analysis set)	0.14% 10/7002 • Number of events 10 • On treatment (safety analysis set)
Vascular disorders ARTERIOSCLEROSIS	0.10% 7/7012 • Number of events 7 • On treatment (safety analysis set)	0.11% 8/7012 • Number of events 8 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Vascular disorders PERIPHERAL VASCULAR DISORDER	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.11% 8/7012 • Number of events 12 • On treatment (safety analysis set)	0.07% 5/7002 • Number of events 7 • On treatment (safety analysis set)
Vascular disorders ORTHOSTATIC HYPOTENSION	0.13% 9/7012 • Number of events 11 • On treatment (safety analysis set)	0.10% 7/7012 • Number of events 8 • On treatment (safety analysis set)	0.13% 9/7002 • Number of events 9 • On treatment (safety analysis set)
Vascular disorders ARTERIOSCLEROSIS OBLITERANS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 6 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Vascular disorders AORTIC ANEURYSM RUPTURE	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Vascular disorders BLEEDING VARICOSE VEIN	0.00% 0/7012 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Vascular disorders VARICOSE VEIN	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders ALVEOLITIS ALLERGIC	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders ASTHMATIC CRISIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders BRONCHIAL HAEMORRHAGE	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders BRONCHIAL SECRETION RETENTION	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders BRONCHITIS CHRONIC	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders BRONCHOMALACIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders CHOKING	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders DIAPHRAGMATIC HERNIA	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders HYDROPNEUMOTHORAX	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders HYDROTHORAX	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders HYPERCAPNIA	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders LARYNGEAL DISORDER	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders LARYNGEAL OEDEMA	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders NASAL CYST	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders NASAL SEPTUM DEVIATION	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders NOCTURNAL DYSPNOEA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders OBSTRUCTIVE AIRWAYS DISORDER	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	1.2% 83/7012 • Number of events 85 • On treatment (safety analysis set)	1.3% 89/7012 • Number of events 97 • On treatment (safety analysis set)	0.84% 59/7002 • Number of events 64 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders PHARYNGEAL HAEMATOMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders PHARYNGEAL HAEMORRHAGE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders PHARYNGEAL MASS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders PICKWICKIAN SYNDROME	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders PLEURISY	0.04% 3/7012 • Number of events 4 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders PLEURITIC PAIN	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders PULMONARY ALVEOLAR HAEMORRHAGE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders PULMONARY ARTERIAL HYPERTENSION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 2 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders PULMONARY ARTERY THROMBOSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders PULMONARY GRANULOMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders RESPIRATORY ACIDOSIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders RESPIRATORY TRACT HAEMORRHAGE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders SINUS POLYP	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders TRACHEAL MASS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders VOCAL CORD POLYP	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders RECTAL HAEMORRHAGE	0.34% 24/7012 • Number of events 28 • On treatment (safety analysis set)	0.60% 42/7012 • Number of events 44 • On treatment (safety analysis set)	0.40% 28/7002 • Number of events 30 • On treatment (safety analysis set)
Gastrointestinal disorders INGUINAL HERNIA	0.34% 24/7012 • Number of events 25 • On treatment (safety analysis set)	0.47% 33/7012 • Number of events 37 • On treatment (safety analysis set)	0.51% 36/7002 • Number of events 36 • On treatment (safety analysis set)
Gastrointestinal disorders UPPER GASTROINTESTINAL HAEMORRHAGE	0.40% 28/7012 • Number of events 32 • On treatment (safety analysis set)	0.41% 29/7012 • Number of events 33 • On treatment (safety analysis set)	0.54% 38/7002 • Number of events 41 • On treatment (safety analysis set)
Gastrointestinal disorders GASTRITIS	0.16% 11/7012 • Number of events 12 • On treatment (safety analysis set)	0.39% 27/7012 • Number of events 28 • On treatment (safety analysis set)	0.17% 12/7002 • Number of events 12 • On treatment (safety analysis set)
Gastrointestinal disorders MELAENA	0.11% 8/7012 • Number of events 9 • On treatment (safety analysis set)	0.37% 26/7012 • Number of events 27 • On treatment (safety analysis set)	0.10% 7/7002 • Number of events 8 • On treatment (safety analysis set)
Gastrointestinal disorders LOWER GASTROINTESTINAL HAEMORRHAGE	0.31% 22/7012 • Number of events 23 • On treatment (safety analysis set)	0.27% 19/7012 • Number of events 19 • On treatment (safety analysis set)	0.19% 13/7002 • Number of events 13 • On treatment (safety analysis set)
Gastrointestinal disorders COLONIC POLYP	0.13% 9/7012 • Number of events 10 • On treatment (safety analysis set)	0.26% 18/7012 • Number of events 19 • On treatment (safety analysis set)	0.23% 16/7002 • Number of events 17 • On treatment (safety analysis set)
Gastrointestinal disorders DIARRHOEA	0.24% 17/7012 • Number of events 17 • On treatment (safety analysis set)	0.24% 17/7012 • Number of events 17 • On treatment (safety analysis set)	0.10% 7/7002 • Number of events 7 • On treatment (safety analysis set)
Gastrointestinal disorders PANCREATITIS ACUTE	0.19% 13/7012 • Number of events 14 • On treatment (safety analysis set)	0.20% 14/7012 • Number of events 14 • On treatment (safety analysis set)	0.27% 19/7002 • Number of events 27 • On treatment (safety analysis set)
Gastrointestinal disorders SMALL INTESTINAL OBSTRUCTION	0.13% 9/7012 • Number of events 13 • On treatment (safety analysis set)	0.20% 14/7012 • Number of events 16 • On treatment (safety analysis set)	0.16% 11/7002 • Number of events 12 • On treatment (safety analysis set)
Gastrointestinal disorders HAEMATOCHEZIA	0.11% 8/7012 • Number of events 8 • On treatment (safety analysis set)	0.19% 13/7012 • Number of events 13 • On treatment (safety analysis set)	0.14% 10/7002 • Number of events 10 • On treatment (safety analysis set)
Gastrointestinal disorders PANCREATITIS	0.33% 23/7012 • Number of events 23 • On treatment (safety analysis set)	0.19% 13/7012 • Number of events 14 • On treatment (safety analysis set)	0.09% 6/7002 • Number of events 6 • On treatment (safety analysis set)
Gastrointestinal disorders ILEUS	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.16% 11/7012 • Number of events 12 • On treatment (safety analysis set)	0.09% 6/7002 • Number of events 7 • On treatment (safety analysis set)
Gastrointestinal disorders GASTRITIS EROSIVE	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.14% 10/7012 • Number of events 10 • On treatment (safety analysis set)	0.14% 10/7002 • Number of events 10 • On treatment (safety analysis set)
Gastrointestinal disorders HAEMORRHOIDAL HAEMORRHAGE	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.14% 10/7012 • Number of events 11 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Gastrointestinal disorders INTESTINAL OBSTRUCTION	0.11% 8/7012 • Number of events 8 • On treatment (safety analysis set)	0.14% 10/7012 • Number of events 11 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Gastrointestinal disorders ABDOMINAL PAIN	0.13% 9/7012 • Number of events 10 • On treatment (safety analysis set)	0.13% 9/7012 • Number of events 10 • On treatment (safety analysis set)	0.16% 11/7002 • Number of events 12 • On treatment (safety analysis set)
Gastrointestinal disorders CONSTIPATION	0.19% 13/7012 • Number of events 14 • On treatment (safety analysis set)	0.13% 9/7012 • Number of events 9 • On treatment (safety analysis set)	0.07% 5/7002 • Number of events 5 • On treatment (safety analysis set)
Gastrointestinal disorders DYSPEPSIA	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.11% 8/7012 • Number of events 8 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Gastrointestinal disorders UMBILICAL HERNIA	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.11% 8/7012 • Number of events 8 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Gastrointestinal disorders HAEMATEMESIS	0.10% 7/7012 • Number of events 7 • On treatment (safety analysis set)	0.10% 7/7012 • Number of events 7 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Gastrointestinal disorders HAEMORRHOIDS	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.10% 7/7012 • Number of events 7 • On treatment (safety analysis set)	0.09% 6/7002 • Number of events 6 • On treatment (safety analysis set)
Gastrointestinal disorders DUODENAL ULCER	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.09% 6/7012 • Number of events 7 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.07% 5/7002 • Number of events 5 • On treatment (safety analysis set)
Gastrointestinal disorders GASTRIC ULCER	0.19% 13/7012 • Number of events 14 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 6 • On treatment (safety analysis set)	0.16% 11/7002 • Number of events 11 • On treatment (safety analysis set)
Gastrointestinal disorders GASTRIC ULCER HAEMORRHAGE	0.13% 9/7012 • Number of events 9 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.11% 8/7002 • Number of events 8 • On treatment (safety analysis set)
Gastrointestinal disorders GASTRITIS HAEMORRHAGIC	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders VOMITING	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 6 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.09% 6/7002 • Number of events 7 • On treatment (safety analysis set)
Gastrointestinal disorders ABDOMINAL STRANGULATED HERNIA	0.00% 0/7012 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Gastrointestinal disorders ASCITES	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Gastrointestinal disorders COLITIS	0.07% 5/7012 • Number of events 6 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.09% 6/7002 • Number of events 6 • On treatment (safety analysis set)
Gastrointestinal disorders GASTRIC HAEMORRHAGE	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders GASTRIC POLYPS	0.00% 0/7012 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders INTESTINAL HAEMORRHAGE	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 5 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders LARGE INTESTINAL HAEMORRHAGE	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Gastrointestinal disorders ABDOMINAL HERNIA	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Gastrointestinal disorders ABDOMINAL PAIN LOWER	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders COLITIS ISCHAEMIC	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Gastrointestinal disorders DENTAL CARIES	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders DIVERTICULUM	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders FAECALOMA	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 4 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Gastrointestinal disorders FAECES DISCOLOURED	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders GASTRIC ANTRAL VASCULAR ECTASIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 4 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders HIATUS HERNIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Gastrointestinal disorders INGUINAL HERNIA STRANGULATED	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Gastrointestinal disorders NAUSEA	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Gastrointestinal disorders PANCREATIC MASS	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders PERIODONTITIS	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.10% 7/7002 • Number of events 7 • On treatment (safety analysis set)
Gastrointestinal disorders RETROPERITONEAL HAEMORRHAGE	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Gastrointestinal disorders ANAL HAEMORRHAGE	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Gastrointestinal disorders CAECITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders DIARRHOEA HAEMORRHAGIC	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders DIVERTICULAR PERFORATION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Gastrointestinal disorders DIVERTICULUM INTESTINAL HAEMORRHAGIC	0.10% 7/7012 • Number of events 7 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Gastrointestinal disorders DYSPHAGIA	0.07% 5/7012 • Number of events 6 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Gastrointestinal disorders FEMORAL HERNIA, OBSTRUCTIVE	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Gastrointestinal disorders GASTROINTESTINAL VASCULAR MALFORMATION	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders INGUINAL HERNIA, OBSTRUCTIVE	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.07% 5/7002 • Number of events 5 • On treatment (safety analysis set)
Gastrointestinal disorders INTESTINAL POLYP	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders LARGE INTESTINE PERFORATION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Gastrointestinal disorders REFLUX GASTRITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders PEPTIC ULCER	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders PEPTIC ULCER HAEMORRHAGE	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders POLYP COLORECTAL	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders UMBILICAL HERNIA, OBSTRUCTIVE	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Gastrointestinal disorders ABDOMINAL ADHESIONS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 2 • On treatment (safety analysis set)
Gastrointestinal disorders ABDOMINAL HERNIA OBSTRUCTIVE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders ANAL FISSURE	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders CHRONIC GASTROINTESTINAL BLEEDING	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders COLITIS MICROSCOPIC	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders COLITIS ULCERATIVE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders COLONIC STENOSIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders CROHN'S DISEASE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders DIVERTICULUM INTESTINAL	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.07% 5/7002 • Number of events 5 • On treatment (safety analysis set)
Gastrointestinal disorders DUODENAL POLYP	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders DUODENITIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders ENTEROCOLITIS HAEMORRHAGIC	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders LIP HAEMORRHAGE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders FAECAL INCONTINENCE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders FEMORAL HERNIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Gastrointestinal disorders GASTRIC DYSPLASIA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders GASTRIC MUCOSAL LESION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders GASTRITIS ATROPHIC	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders GASTRODUODENITIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders GASTROINTESTINAL INFLAMMATION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders GASTROINTESTINAL TOXICITY	0.01% 1/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders GASTROINTESTINAL ULCER HAEMORRHAGE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders GINGIVAL BLEEDING	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders GLOSSITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders HAEMORRHAGIC EROSIVE GASTRITIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders ILEUS PARALYTIC	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Gastrointestinal disorders INFLAMMATORY BOWEL DISEASE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders INTESTINAL ISCHAEMIA	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.09% 6/7002 • Number of events 6 • On treatment (safety analysis set)
Gastrointestinal disorders INTESTINAL MASS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Gastrointestinal disorders INTESTINAL POLYP HAEMORRHAGE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders INTESTINAL STENOSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders MOUTH HAEMORRHAGE	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Gastrointestinal disorders OESOPHAGEAL FOOD IMPACTION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders OESOPHAGEAL HAEMORRHAGE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders OESOPHAGEAL RUPTURE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders OESOPHAGEAL SPASM	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders OESOPHAGEAL STENOSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders OESOPHAGEAL ULCER	0.01% 1/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders OESOPHAGITIS	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders PANCREATIC NECROSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders PANCREATITIS CHRONIC	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders PANCREATITIS NECROTISING	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders PERIODONTAL DISEASE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders PNEUMOPERITONEUM	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders PROTEIN-LOSING GASTROENTEROPATHY	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders PYLORUS DILATATION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders RADICULAR CYST	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders RECTAL POLYP	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders RECTAL ULCER	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders RETROPERITONEAL HAEMATOMA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders ABDOMINAL DISTENSION	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders ABDOMINAL MASS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders ABDOMINAL WALL HAEMATOMA	0.04% 3/7012 • Number of events 4 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders ACUTE ABDOMEN	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders ALCOHOLIC PANCREATITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 2 • On treatment (safety analysis set)
Gastrointestinal disorders ANAL FISTULA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders ANAL ULCER HAEMORRHAGE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders COELIAC DISEASE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders COLON DYSPLASIA	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders COLONIC FISTULA	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders COLONIC PSEUDO-OBSTRUCTION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders DIABETIC GASTROPATHY	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders DIVERTICULITIS INTESTINAL HAEMORRHAGIC	0.03% 2/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders DIVERTICULUM OESOPHAGEAL	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders DUODENAL ULCER HAEMORRHAGE	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders ENTERITIS	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders ENTEROCOLITIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Gastrointestinal disorders ENTEROVESICAL FISTULA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders FOOD POISONING	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Gastrointestinal disorders GASTRIC VARICES	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders GASTRODUODENAL ULCER	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders GASTROINTESTINAL DISORDER	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders GASTROINTESTINAL DYSPLASIA	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders GASTROINTESTINAL HYPOMOTILITY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders GASTROINTESTINAL ISCHAEMIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders GASTROINTESTINAL NECROSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Gastrointestinal disorders GASTROINTESTINAL OBSTRUCTION	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders GASTROINTESTINAL PERFORATION	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders GASTROPLEURAL FISTULA	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders GIANT CELL EPULIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders ILEITIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders INTESTINAL HAEMATOMA	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders INTESTINAL INFARCTION	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders INTESTINAL PERFORATION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Gastrointestinal disorders LARGE INTESTINAL OBSTRUCTION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders LARGE INTESTINAL ULCER	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders MALLORY-WEISS SYNDROME	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders MESENTERIC ARTERY EMBOLISM	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders MESENTERIC ARTERY THROMBOSIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders MESENTERIC VEIN THROMBOSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders MOUTH ULCERATION	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders ODYNOPHAGIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders OESOPHAGEAL ACHALASIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders OESOPHAGEAL VARICES HAEMORRHAGE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders ORAL DYSAESTHESIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders PANCREATIC CYST	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders PANCREATITIS RELAPSING	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 2 • On treatment (safety analysis set)
Gastrointestinal disorders PANCREATOLITHIASIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders PAROTID GLAND INFLAMMATION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders PERITONEAL HAEMORRHAGE	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Gastrointestinal disorders PNEUMATOSIS INTESTINALIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders POOR DENTAL CONDITION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders PROCTALGIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders RECTAL PROLAPSE	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders SALIVARY GLAND CALCULUS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders SMALL INTESTINAL HAEMORRHAGE	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Gastrointestinal disorders SMALL INTESTINAL PERFORATION	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders SPIGELIAN HERNIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders SUBILEUS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Gastrointestinal disorders TONGUE CYST	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Gastrointestinal disorders TOOTHACHE	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Gastrointestinal disorders VARICES OESOPHAGEAL	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Hepatobiliary disorders BILE DUCT OBSTRUCTION	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Hepatobiliary disorders BILIARY COLIC	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Hepatobiliary disorders AMPULLA OF VATER STENOSIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Hepatobiliary disorders CHOLANGITIS	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Hepatobiliary disorders HEPATIC FAILURE	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Hepatobiliary disorders HEPATIC FUNCTION ABNORMAL	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Hepatobiliary disorders ISCHAEMIC HEPATITIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Hepatobiliary disorders ACUTE HEPATIC FAILURE	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Hepatobiliary disorders ALCOHOLIC LIVER DISEASE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Hepatobiliary disorders BILIARY FISTULA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Hepatobiliary disorders CHOLANGITIS ACUTE	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Hepatobiliary disorders GALLBLADDER POLYP	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Hepatobiliary disorders HEPATIC CYST	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Hepatobiliary disorders HEPATIC CYST RUPTURED	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Hepatobiliary disorders HEPATIC STEATOSIS	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Hepatobiliary disorders HEPATITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Hepatobiliary disorders HEPATOTOXICITY	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Hepatobiliary disorders HYDROCHOLECYSTIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Hepatobiliary disorders JAUNDICE CHOLESTATIC	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.07% 5/7002 • Number of events 5 • On treatment (safety analysis set)
Hepatobiliary disorders BILE DUCT STENOSIS	0.03% 2/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Hepatobiliary disorders BILIARY DYSKINESIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Hepatobiliary disorders CHOLELITHIASIS OBSTRUCTIVE	0.01% 1/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Hepatobiliary disorders CHOLESTASIS	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Hepatobiliary disorders CHRONIC HEPATIC FAILURE	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Hepatobiliary disorders GALLBLADDER DISORDER	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Hepatobiliary disorders HAEMOBILIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Hepatobiliary disorders HEPATIC CONGESTION	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 3 • On treatment (safety analysis set)
Hepatobiliary disorders HEPATIC ISCHAEMIA	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Hepatobiliary disorders HEPATITIS ACUTE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders LEUKOCYTOCLASTIC VASCULITIS	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Hepatobiliary disorders HEPATITIS ALCOHOLIC	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Hepatobiliary disorders HEPATITIS TOXIC	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Hepatobiliary disorders HEPATOMEGALY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Hepatobiliary disorders HEPATORENAL FAILURE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Hepatobiliary disorders HEPATORENAL SYNDROME	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Hepatobiliary disorders HYPERBILIRUBINAEMIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Hepatobiliary disorders LIVER DISORDER	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Hepatobiliary disorders LIVER INJURY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Hepatobiliary disorders PORTAL VEIN THROMBOSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Hepatobiliary disorders POST CHOLECYSTECTOMY SYNDROME	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders SKIN ULCER	0.17% 12/7012 • Number of events 13 • On treatment (safety analysis set)	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.20% 14/7002 • Number of events 14 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders SKIN HAEMORRHAGE	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders ANGIOEDEMA	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders DECUBITUS ULCER	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders DERMAL CYST	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders ACTINIC KERATOSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders DERMATITIS ALLERGIC	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders DERMATITIS CONTACT	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders DERMATOMYOSITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders DRUG ERUPTION	0.04% 3/7012 • Number of events 4 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders DRY GANGRENE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders ECCHYMOSIS	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders ERYTHEMA MULTIFORME	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders HYPERKERATOSIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders PSORIASIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders PURPURA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders RASH	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders SKIN NECROSIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders STASIS DERMATITIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders STEVENS-JOHNSON SYNDROME	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders ACANTHOSIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders CUTANEOUS LUPUS ERYTHEMATOSUS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders DERMATITIS	0.01% 1/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders DERMATITIS ATOPIC	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders ECZEMA	0.03% 2/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders ECZEMA NUMMULAR	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders GRANULOMA SKIN	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders HAEMORRHAGE SUBCUTANEOUS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders HENOCH-SCHONLEIN PURPURA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders HYPERHIDROSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders INGROWING NAIL	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders NEURODERMATITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders PANNICULITIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders PEMPHIGOID	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders PRURIGO	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders SCAR	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders SEBORRHOEIC DERMATITIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders SKIN LESION	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders SKIN ULCER HAEMORRHAGE	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders SUBCUTANEOUS NODULE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders SWELLING FACE	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Skin and subcutaneous tissue disorders URTICARIA	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	0.88% 62/7012 • Number of events 69 • On treatment (safety analysis set)	1.00% 70/7012 • Number of events 78 • On treatment (safety analysis set)	0.87% 61/7002 • Number of events 65 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders BACK PAIN	0.20% 14/7012 • Number of events 14 • On treatment (safety analysis set)	0.23% 16/7012 • Number of events 17 • On treatment (safety analysis set)	0.17% 12/7002 • Number of events 12 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders ARTHRITIS	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.19% 13/7012 • Number of events 13 • On treatment (safety analysis set)	0.14% 10/7002 • Number of events 11 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders LUMBAR SPINAL STENOSIS	0.16% 11/7012 • Number of events 12 • On treatment (safety analysis set)	0.11% 8/7012 • Number of events 11 • On treatment (safety analysis set)	0.13% 9/7002 • Number of events 10 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.10% 7/7012 • Number of events 9 • On treatment (safety analysis set)	0.11% 8/7002 • Number of events 8 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.09% 6/7012 • Number of events 7 • On treatment (safety analysis set)	0.10% 7/7002 • Number of events 7 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC PROTRUSION	0.21% 15/7012 • Number of events 16 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.10% 7/7002 • Number of events 9 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	0.14% 10/7012 • Number of events 13 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders SPINAL OSTEOARTHRITIS	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.20% 14/7002 • Number of events 15 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders COSTOCHONDRITIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders HAEMARTHROSIS	0.10% 7/7012 • Number of events 7 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders OSTEOPOROSIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders SPINAL COLUMN STENOSIS	0.13% 9/7012 • Number of events 10 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.20% 14/7002 • Number of events 16 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders SYNOVIAL CYST	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders GOUTY ARTHRITIS	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.10% 7/7002 • Number of events 9 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC DISORDER	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders OSTEONECROSIS	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders POLYARTHRITIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders RHEUMATOID ARTHRITIS	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders ANKYLOSING SPONDYLITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders ARTHROPATHY	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders AXILLARY MASS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders BONE PAIN	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders BURSITIS	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders CERVICAL SPINAL STENOSIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders CHONDROCALCINOSIS PYROPHOSPHATE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders INCLUSION BODY MYOSITIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders JOINT INSTABILITY	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders MYALGIA	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 3 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders MYOSITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders OSTEOPOROTIC FRACTURE	0.01% 1/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders PATHOLOGICAL FRACTURE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders PERIARTHRITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders PERIOSTITIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders POLYMYALGIA RHEUMATICA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders RHABDOMYOLYSIS	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.07% 5/7002 • Number of events 5 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders ROTATOR CUFF SYNDROME	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.10% 7/7002 • Number of events 7 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders SPONDYLITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders SPONDYLOARTHROPATHY	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders SPONDYLOLISTHESIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders SYNOVITIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders TORTICOLLIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders TRIGGER FINGER	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 2 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders ARTICULAR CALCIFICATION	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders BACK DISORDER	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders BONE CYST	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders CHONDROPATHY	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders DEFORMITY THORAX	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders DUPUYTREN'S CONTRACTURE	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 4 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders EXOSTOSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders FASCIITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders FISTULA	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders FOOT DEFORMITY	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.07% 5/7002 • Number of events 5 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders FRACTURE MALUNION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders GOUTY TOPHUS	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders GROIN PAIN	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC COMPRESSION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC DEGENERATION	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders JOINT EFFUSION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders JOINT SWELLING	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders LATERAL PATELLAR COMPRESSION SYNDROME	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders MUSCLE ATROPHY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders MUSCLE DISORDER	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders MUSCLE HAEMORRHAGE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.07% 5/7002 • Number of events 5 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders MUSCLE TWITCHING	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL DISCOMFORT	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders MYOPATHY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders NECK PAIN	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders NEUROPATHIC ARTHROPATHY	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders OSTEITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders OSTEOCHONDROSIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 5 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders OSTEONECROSIS OF JAW	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders SCOLIOSIS	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders SPINAL DISORDER	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders SYMPATHETIC POSTERIOR CERVICAL SYNDROME	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders TENDONITIS	0.01% 1/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders UNDIFFERENTIATED CONNECTIVE TISSUE DISEASE	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Renal and urinary disorders HAEMATURIA	0.91% 64/7012 • Number of events 67 • On treatment (safety analysis set)	0.97% 68/7012 • Number of events 71 • On treatment (safety analysis set)	0.81% 57/7002 • Number of events 60 • On treatment (safety analysis set)
Renal and urinary disorders RENAL FAILURE ACUTE	0.90% 63/7012 • Number of events 68 • On treatment (safety analysis set)	0.76% 53/7012 • Number of events 56 • On treatment (safety analysis set)	0.89% 62/7002 • Number of events 67 • On treatment (safety analysis set)
Renal and urinary disorders RENAL FAILURE	0.41% 29/7012 • Number of events 30 • On treatment (safety analysis set)	0.41% 29/7012 • Number of events 30 • On treatment (safety analysis set)	0.23% 16/7002 • Number of events 17 • On treatment (safety analysis set)
Renal and urinary disorders NEPHROLITHIASIS	0.10% 7/7012 • Number of events 8 • On treatment (safety analysis set)	0.24% 17/7012 • Number of events 19 • On treatment (safety analysis set)	0.10% 7/7002 • Number of events 8 • On treatment (safety analysis set)
Renal and urinary disorders RENAL FAILURE CHRONIC	0.20% 14/7012 • Number of events 15 • On treatment (safety analysis set)	0.19% 13/7012 • Number of events 14 • On treatment (safety analysis set)	0.17% 12/7002 • Number of events 14 • On treatment (safety analysis set)
Renal and urinary disorders CALCULUS URETERIC	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.13% 9/7012 • Number of events 9 • On treatment (safety analysis set)	0.11% 8/7002 • Number of events 8 • On treatment (safety analysis set)
Renal and urinary disorders URINARY RETENTION	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.10% 7/7012 • Number of events 7 • On treatment (safety analysis set)	0.13% 9/7002 • Number of events 9 • On treatment (safety analysis set)
Renal and urinary disorders CALCULUS URINARY	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.09% 6/7012 • Number of events 7 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Renal and urinary disorders RENAL IMPAIRMENT	0.10% 7/7012 • Number of events 8 • On treatment (safety analysis set)	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.19% 13/7002 • Number of events 15 • On treatment (safety analysis set)
Renal and urinary disorders ACUTE PRERENAL FAILURE	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Renal and urinary disorders RENAL CYST	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 5 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Renal and urinary disorders URETHRAL STENOSIS	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Renal and urinary disorders CALCULUS BLADDER	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Renal and urinary disorders DIABETIC NEPHROPATHY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Renal and urinary disorders RENAL ARTERY STENOSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Renal and urinary disorders STAG HORN CALCULUS	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Renal and urinary disorders RENAL COLIC	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Renal and urinary disorders RENAL INFARCT	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Renal and urinary disorders URINARY INCONTINENCE	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 2 • On treatment (safety analysis set)
Renal and urinary disorders AZOTAEMIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Renal and urinary disorders BLADDER MASS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Renal and urinary disorders BLADDER STENOSIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Renal and urinary disorders BLADDER TAMPONADE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Renal and urinary disorders CYSTITIS GLANDULARIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Renal and urinary disorders CYSTITIS HAEMORRHAGIC	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Renal and urinary disorders DYSURIA	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Renal and urinary disorders HYDRONEPHROSIS	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.07% 5/7002 • Number of events 5 • On treatment (safety analysis set)
Renal and urinary disorders NEPHROPATHY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Renal and urinary disorders NEPHROSCLEROSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Renal and urinary disorders NEPHROTIC SYNDROME	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Renal and urinary disorders OBSTRUCTIVE UROPATHY	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Renal and urinary disorders POLLAKIURIA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Renal and urinary disorders POLYURIA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Renal and urinary disorders RENAL INJURY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Renal and urinary disorders STRESS URINARY INCONTINENCE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Renal and urinary disorders TUBULOINTERSTITIAL NEPHRITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Renal and urinary disorders URETHRAL HAEMORRHAGE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Renal and urinary disorders URINARY BLADDER POLYP	0.01% 1/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Renal and urinary disorders URINARY TRACT DISORDER	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Renal and urinary disorders BLADDER OUTLET OBSTRUCTION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Renal and urinary disorders BLADDER PROLAPSE	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Renal and urinary disorders CYSTITIS NONINFECTIVE	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Renal and urinary disorders GLOMERULONEPHRITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Renal and urinary disorders GLOMERULONEPHROPATHY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Renal and urinary disorders HAEMORRHAGE URINARY TRACT	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Renal and urinary disorders HYPERTENSIVE NEPHROPATHY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Renal and urinary disorders NEPHRITIS AUTOIMMUNE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Renal and urinary disorders NEUROGENIC BLADDER	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Renal and urinary disorders RENAL MASS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Renal and urinary disorders RENAL TUBULAR NECROSIS	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Renal and urinary disorders URETERIC STENOSIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Renal and urinary disorders URETHRAL DISCHARGE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Renal and urinary disorders URETHRAL OBSTRUCTION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Renal and urinary disorders URETHRAL POLYP	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Renal and urinary disorders URINARY BLADDER HAEMORRHAGE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Renal and urinary disorders URINARY TRACT OBSTRUCTION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Renal and urinary disorders UROGENITAL HAEMORRHAGE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Reproductive system and breast disorders BENIGN PROSTATIC HYPERPLASIA	0.50% 35/7012 • Number of events 37 • On treatment (safety analysis set)	0.41% 29/7012 • Number of events 31 • On treatment (safety analysis set)	0.24% 17/7002 • Number of events 18 • On treatment (safety analysis set)
Reproductive system and breast disorders PROSTATITIS	0.09% 6/7012 • Number of events 7 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Reproductive system and breast disorders VAGINAL HAEMORRHAGE	0.10% 7/7012 • Number of events 7 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Reproductive system and breast disorders METRORRHAGIA	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Reproductive system and breast disorders PROSTATOMEGALY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Reproductive system and breast disorders UTERINE POLYP	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Reproductive system and breast disorders BREAST MASS	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Reproductive system and breast disorders CERVIX HAEMORRHAGE UTERINE	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Reproductive system and breast disorders ACQUIRED HYDROCELE	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Reproductive system and breast disorders ACQUIRED PHIMOSIS	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Reproductive system and breast disorders BALANITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Reproductive system and breast disorders CERVICAL POLYP	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Reproductive system and breast disorders CERVIX HAEMATOMA UTERINE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Reproductive system and breast disorders COLPOCELE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Reproductive system and breast disorders ENDOMETRIAL HYPERPLASIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Reproductive system and breast disorders EPIDIDYMITIS	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Reproductive system and breast disorders GENITAL HAEMORRHAGE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Reproductive system and breast disorders OVARIAN CYST	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Reproductive system and breast disorders POSTMENOPAUSAL HAEMORRHAGE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Reproductive system and breast disorders PROSTATISM	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Reproductive system and breast disorders RECTOCELE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Reproductive system and breast disorders UTERINE HAEMORRHAGE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.10% 7/7002 • Number of events 7 • On treatment (safety analysis set)
Reproductive system and breast disorders UTERINE PROLAPSE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Reproductive system and breast disorders BREAST CALCIFICATIONS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Reproductive system and breast disorders BREAST CYST	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 2 • On treatment (safety analysis set)
Reproductive system and breast disorders BREAST PAIN	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Reproductive system and breast disorders ENDOMETRIAL HYPERTROPHY	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Reproductive system and breast disorders ENDOMETRIOSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Reproductive system and breast disorders FEMALE GENITAL TRACT FISTULA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Reproductive system and breast disorders GYNAECOMASTIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Reproductive system and breast disorders OVARIAN MASS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Reproductive system and breast disorders PELVIC PAIN	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Reproductive system and breast disorders PENILE HAEMORRHAGE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Reproductive system and breast disorders PROSTATIC DYSPLASIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Reproductive system and breast disorders PROSTATIC OBSTRUCTION	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Reproductive system and breast disorders SCROTAL OEDEMA	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Reproductive system and breast disorders UTERINE CYST	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Reproductive system and breast disorders VAGINAL PROLAPSE	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Congenital, familial and genetic disorders ARTERIOVENOUS MALFORMATION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Congenital, familial and genetic disorders DIVERTICULITIS MECKEL'S	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Congenital, familial and genetic disorders GASTROINTESTINAL ANGIODYSPLASIA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Congenital, familial and genetic disorders GASTROINTESTINAL ANGIODYSPLASIA HAEMORRHAGIC	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Congenital, familial and genetic disorders GITELMAN'S SYNDROME	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Congenital, familial and genetic disorders HAEMORRHAGIC ARTERIOVENOUS MALFORMATION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Congenital, familial and genetic disorders HIP DYSPLASIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Congenital, familial and genetic disorders HYDROCELE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Congenital, familial and genetic disorders ATRIAL SEPTAL DEFECT	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Congenital, familial and genetic disorders FRIEDREICH'S ATAXIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Congenital, familial and genetic disorders PENOSCROTAL FUSION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Congenital, familial and genetic disorders PHIMOSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Congenital, familial and genetic disorders RILEY-DAY SYNDROME	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Congenital, familial and genetic disorders VENTRICULAR SEPTAL DEFECT	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
General disorders DEATH	1.3% 91/7012 • Number of events 91 • On treatment (safety analysis set)	1.1% 80/7012 • Number of events 80 • On treatment (safety analysis set)	1.1% 78/7002 • Number of events 78 • On treatment (safety analysis set)
General disorders NON-CARDIAC CHEST PAIN	0.56% 39/7012 • Number of events 40 • On treatment (safety analysis set)	0.71% 50/7012 • Number of events 54 • On treatment (safety analysis set)	0.77% 54/7002 • Number of events 58 • On treatment (safety analysis set)
General disorders SUDDEN DEATH	0.64% 45/7012 • Number of events 46 • On treatment (safety analysis set)	0.41% 29/7012 • Number of events 29 • On treatment (safety analysis set)	0.50% 35/7002 • Number of events 35 • On treatment (safety analysis set)
General disorders CHEST PAIN	0.34% 24/7012 • Number of events 26 • On treatment (safety analysis set)	0.37% 26/7012 • Number of events 27 • On treatment (safety analysis set)	0.47% 33/7002 • Number of events 35 • On treatment (safety analysis set)
General disorders SUDDEN CARDIAC DEATH	0.34% 24/7012 • Number of events 24 • On treatment (safety analysis set)	0.33% 23/7012 • Number of events 23 • On treatment (safety analysis set)	0.34% 24/7002 • Number of events 24 • On treatment (safety analysis set)
General disorders DEVICE DISLOCATION	0.17% 12/7012 • Number of events 14 • On treatment (safety analysis set)	0.16% 11/7012 • Number of events 13 • On treatment (safety analysis set)	0.09% 6/7002 • Number of events 7 • On treatment (safety analysis set)
General disorders ASTHENIA	0.17% 12/7012 • Number of events 12 • On treatment (safety analysis set)	0.11% 8/7012 • Number of events 8 • On treatment (safety analysis set)	0.24% 17/7002 • Number of events 19 • On treatment (safety analysis set)
General disorders PYREXIA	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.11% 8/7012 • Number of events 8 • On treatment (safety analysis set)	0.14% 10/7002 • Number of events 11 • On treatment (safety analysis set)
General disorders CHEST DISCOMFORT	0.10% 7/7012 • Number of events 7 • On treatment (safety analysis set)	0.10% 7/7012 • Number of events 7 • On treatment (safety analysis set)	0.10% 7/7002 • Number of events 7 • On treatment (safety analysis set)
General disorders MULTI-ORGAN FAILURE	0.20% 14/7012 • Number of events 14 • On treatment (safety analysis set)	0.10% 7/7012 • Number of events 7 • On treatment (safety analysis set)	0.26% 18/7002 • Number of events 18 • On treatment (safety analysis set)
General disorders DEVICE BATTERY ISSUE	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.11% 8/7002 • Number of events 8 • On treatment (safety analysis set)
General disorders DEVICE MALFUNCTION	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 6 • On treatment (safety analysis set)	0.10% 7/7002 • Number of events 7 • On treatment (safety analysis set)
General disorders OEDEMA PERIPHERAL	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
General disorders GENERAL PHYSICAL HEALTH DETERIORATION	0.10% 7/7012 • Number of events 7 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.10% 7/7002 • Number of events 9 • On treatment (safety analysis set)
General disorders DEVICE FAILURE	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
General disorders FATIGUE	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
General disorders SYSTEMIC INFLAMMATORY RESPONSE SYNDROME	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
General disorders ADVERSE DRUG REACTION	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
General disorders CARDIAC DEATH	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.07% 5/7002 • Number of events 5 • On treatment (safety analysis set)
General disorders GAIT DISTURBANCE	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
General disorders MEDICAL DEVICE COMPLICATION	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
General disorders APPLICATION SITE BLEEDING	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
General disorders CALCINOSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
General disorders DEVICE CONNECTION ISSUE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
General disorders DEVICE LEAD DAMAGE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
General disorders DEVICE PACING ISSUE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
General disorders DISCOMFORT	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
General disorders DRUG WITHDRAWAL SYNDROME	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
General disorders GRAVITATIONAL OEDEMA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
General disorders HERNIA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
General disorders HERNIA OBSTRUCTIVE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
General disorders IMPAIRED HEALING	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
General disorders IMPLANT SITE HAEMATOMA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
General disorders IMPLANT SITE REACTION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
General disorders INFLUENZA LIKE ILLNESS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
General disorders INJECTION SITE HAEMATOMA	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
General disorders ISCHAEMIC ULCER	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
General disorders MUCOSAL HAEMORRHAGE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
General disorders OEDEMA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
General disorders PACEMAKER SYNDROME	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
General disorders PUNCTURE SITE HAEMORRHAGE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
General disorders VESSEL PUNCTURE SITE HAEMATOMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
General disorders ACCIDENTAL DEATH	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
General disorders CATHETER SITE HAEMORRHAGE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
General disorders DEVICE BREAKAGE	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
General disorders DEVICE CAPTURING ISSUE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
General disorders DEVICE ISSUE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
General disorders DEVICE LEAD ISSUE	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
General disorders DEVICE LEAKAGE	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
General disorders DEVICE OCCLUSION	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
General disorders DROWNING	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
General disorders GENERALISED OEDEMA	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
General disorders IMPLANT SITE EROSION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
General disorders IMPLANT SITE IRRITATION	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
General disorders INFLAMMATION	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
General disorders MALAISE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
General disorders PAIN	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
General disorders PERFORATED ULCER	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
General disorders PNEUMATOSIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
General disorders PRODUCT ADHESION ISSUE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
General disorders SOFT TISSUE INFLAMMATION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
General disorders VESSEL PUNCTURE SITE HAEMORRHAGE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
General disorders XEROSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Investigations INTERNATIONAL NORMALISED RATIO INCREASED	1.1% 76/7012 • Number of events 81 • On treatment (safety analysis set)	0.20% 14/7012 • Number of events 14 • On treatment (safety analysis set)	0.36% 25/7002 • Number of events 29 • On treatment (safety analysis set)
Investigations HEPATIC ENZYME INCREASED	0.09% 6/7012 • Number of events 7 • On treatment (safety analysis set)	0.19% 13/7012 • Number of events 13 • On treatment (safety analysis set)	0.07% 5/7002 • Number of events 5 • On treatment (safety analysis set)
Investigations HAEMOGLOBIN DECREASED	0.16% 11/7012 • Number of events 12 • On treatment (safety analysis set)	0.14% 10/7012 • Number of events 11 • On treatment (safety analysis set)	0.10% 7/7002 • Number of events 11 • On treatment (safety analysis set)
Investigations LIVER FUNCTION TEST ABNORMAL	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Investigations OCCULT BLOOD POSITIVE	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.07% 5/7002 • Number of events 5 • On treatment (safety analysis set)
Investigations TRANSAMINASES INCREASED	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Investigations HAEMATOCRIT DECREASED	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Investigations OCCULT BLOOD	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Investigations PROSTATIC SPECIFIC ANTIGEN INCREASED	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 4 • On treatment (safety analysis set)
Investigations 5-HYDROXYINDOLACETIC ACID INCREASED	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Investigations ALANINE AMINOTRANSFERASE INCREASED	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Investigations BLOOD GLUCOSE ABNORMAL	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Investigations BLOOD GLUCOSE INCREASED	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Investigations BLOOD POTASSIUM DECREASED	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Investigations C-REACTIVE PROTEIN INCREASED	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Investigations COAGULATION TIME PROLONGED	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Investigations EJECTION FRACTION ABNORMAL	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Investigations ELECTROCARDIOGRAM ST SEGMENT DEPRESSION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Investigations INTERNATIONAL NORMALISED RATIO DECREASED	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Investigations SCAN MYOCARDIAL PERFUSION ABNORMAL	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Investigations WEIGHT DECREASED	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Investigations ANGIOGRAM	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Investigations ANTICOAGULATION DRUG LEVEL ABOVE THERAPEUTIC	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Investigations BLOOD BILIRUBIN INCREASED	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Investigations BLOOD CREATINE PHOSPHOKINASE INCREASED	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Investigations BLOOD CREATININE INCREASED	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Investigations BLOOD ELECTROLYTES INCREASED	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Investigations BLOOD OSMOLARITY DECREASED	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Investigations BLOOD PRESSURE DECREASED	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Investigations BLOOD PRESSURE INCREASED	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Investigations BLOOD SODIUM DECREASED	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Investigations BLOOD UREA INCREASED	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Investigations CARDIAC OUTPUT DECREASED	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Investigations CREATININE RENAL CLEARANCE DECREASED	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Investigations EJECTION FRACTION DECREASED	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Investigations ELECTROCARDIOGRAM QT PROLONGED	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Investigations HEART RATE DECREASED	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Investigations HEART RATE INCREASED	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Investigations INTRAOCULAR PRESSURE INCREASED	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Investigations NEUTROPHIL COUNT DECREASED	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Investigations OXYGEN SATURATION DECREASED	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Investigations PROTHROMBIN TIME PROLONGED	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Investigations TROPONIN INCREASED	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Investigations TUMOUR MARKER INCREASED	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Investigations WHITE BLOOD CELL COUNT INCREASED	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications FALL	0.71% 50/7012 • Number of events 51 • On treatment (safety analysis set)	0.67% 47/7012 • Number of events 47 • On treatment (safety analysis set)	0.64% 45/7002 • Number of events 48 • On treatment (safety analysis set)
Injury, poisoning and procedural complications FEMUR FRACTURE	0.43% 30/7012 • Number of events 31 • On treatment (safety analysis set)	0.53% 37/7012 • Number of events 37 • On treatment (safety analysis set)	0.44% 31/7002 • Number of events 31 • On treatment (safety analysis set)
Injury, poisoning and procedural complications POST PROCEDURAL HAEMORRHAGE	0.17% 12/7012 • Number of events 12 • On treatment (safety analysis set)	0.29% 20/7012 • Number of events 20 • On treatment (safety analysis set)	0.23% 16/7002 • Number of events 16 • On treatment (safety analysis set)
Injury, poisoning and procedural complications HIP FRACTURE	0.40% 28/7012 • Number of events 28 • On treatment (safety analysis set)	0.27% 19/7012 • Number of events 19 • On treatment (safety analysis set)	0.41% 29/7002 • Number of events 29 • On treatment (safety analysis set)
Injury, poisoning and procedural complications RIB FRACTURE	0.21% 15/7012 • Number of events 15 • On treatment (safety analysis set)	0.27% 19/7012 • Number of events 19 • On treatment (safety analysis set)	0.26% 18/7002 • Number of events 18 • On treatment (safety analysis set)
Injury, poisoning and procedural complications HUMERUS FRACTURE	0.14% 10/7012 • Number of events 10 • On treatment (safety analysis set)	0.23% 16/7012 • Number of events 17 • On treatment (safety analysis set)	0.24% 17/7002 • Number of events 17 • On treatment (safety analysis set)
Injury, poisoning and procedural complications TRAUMATIC HAEMATOMA	0.57% 40/7012 • Number of events 40 • On treatment (safety analysis set)	0.21% 15/7012 • Number of events 15 • On treatment (safety analysis set)	0.23% 16/7002 • Number of events 16 • On treatment (safety analysis set)
Injury, poisoning and procedural complications SPINAL COMPRESSION FRACTURE	0.27% 19/7012 • Number of events 19 • On treatment (safety analysis set)	0.20% 14/7012 • Number of events 15 • On treatment (safety analysis set)	0.17% 12/7002 • Number of events 14 • On treatment (safety analysis set)
Injury, poisoning and procedural complications TOXICITY TO VARIOUS AGENTS	0.19% 13/7012 • Number of events 13 • On treatment (safety analysis set)	0.20% 14/7012 • Number of events 14 • On treatment (safety analysis set)	0.19% 13/7002 • Number of events 13 • On treatment (safety analysis set)
Injury, poisoning and procedural complications FEMORAL NECK FRACTURE	0.24% 17/7012 • Number of events 17 • On treatment (safety analysis set)	0.17% 12/7012 • Number of events 12 • On treatment (safety analysis set)	0.27% 19/7002 • Number of events 19 • On treatment (safety analysis set)
Injury, poisoning and procedural complications LACERATION	0.19% 13/7012 • Number of events 14 • On treatment (safety analysis set)	0.17% 12/7012 • Number of events 12 • On treatment (safety analysis set)	0.17% 12/7002 • Number of events 12 • On treatment (safety analysis set)
Injury, poisoning and procedural complications OPERATIVE HAEMORRHAGE	0.14% 10/7012 • Number of events 11 • On treatment (safety analysis set)	0.17% 12/7012 • Number of events 12 • On treatment (safety analysis set)	0.07% 5/7002 • Number of events 5 • On treatment (safety analysis set)
Injury, poisoning and procedural complications SUBDURAL HAEMATOMA	0.57% 40/7012 • Number of events 43 • On treatment (safety analysis set)	0.16% 11/7012 • Number of events 12 • On treatment (safety analysis set)	0.14% 10/7002 • Number of events 10 • On treatment (safety analysis set)
Injury, poisoning and procedural complications POST PROCEDURAL HAEMATOMA	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.14% 10/7012 • Number of events 10 • On treatment (safety analysis set)	0.10% 7/7002 • Number of events 7 • On treatment (safety analysis set)
Injury, poisoning and procedural complications LOWER LIMB FRACTURE	0.11% 8/7012 • Number of events 8 • On treatment (safety analysis set)	0.11% 8/7012 • Number of events 8 • On treatment (safety analysis set)	0.07% 5/7002 • Number of events 5 • On treatment (safety analysis set)
Injury, poisoning and procedural complications TRAUMATIC HAEMORRHAGE	0.13% 9/7012 • Number of events 9 • On treatment (safety analysis set)	0.11% 8/7012 • Number of events 8 • On treatment (safety analysis set)	0.13% 9/7002 • Number of events 9 • On treatment (safety analysis set)
Injury, poisoning and procedural complications LUMBAR VERTEBRAL FRACTURE	0.11% 8/7012 • Number of events 8 • On treatment (safety analysis set)	0.10% 7/7012 • Number of events 7 • On treatment (safety analysis set)	0.09% 6/7002 • Number of events 9 • On treatment (safety analysis set)
Injury, poisoning and procedural complications CONCUSSION	0.14% 10/7012 • Number of events 10 • On treatment (safety analysis set)	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.13% 9/7002 • Number of events 9 • On treatment (safety analysis set)
Injury, poisoning and procedural complications FACIAL BONES FRACTURE	0.10% 7/7012 • Number of events 8 • On treatment (safety analysis set)	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.09% 6/7002 • Number of events 7 • On treatment (safety analysis set)
Injury, poisoning and procedural complications PELVIC FRACTURE	0.10% 7/7012 • Number of events 7 • On treatment (safety analysis set)	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.07% 5/7002 • Number of events 5 • On treatment (safety analysis set)
Injury, poisoning and procedural complications FIBULA FRACTURE	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications SUBDURAL HAEMORRHAGE	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Injury, poisoning and procedural complications THORACIC VERTEBRAL FRACTURE	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Injury, poisoning and procedural complications ANKLE FRACTURE	0.19% 13/7012 • Number of events 13 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.13% 9/7002 • Number of events 9 • On treatment (safety analysis set)
Injury, poisoning and procedural complications PUBIS FRACTURE	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.13% 9/7002 • Number of events 9 • On treatment (safety analysis set)
Injury, poisoning and procedural complications ROAD TRAFFIC ACCIDENT	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications CERVICAL VERTEBRAL FRACTURE	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Injury, poisoning and procedural complications CONTUSION	0.37% 26/7012 • Number of events 29 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.21% 15/7002 • Number of events 15 • On treatment (safety analysis set)
Injury, poisoning and procedural complications FOOT FRACTURE	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.09% 6/7002 • Number of events 6 • On treatment (safety analysis set)
Injury, poisoning and procedural complications FOREARM FRACTURE	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Injury, poisoning and procedural complications MUSCLE STRAIN	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications PATELLA FRACTURE	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications POST PROCEDURAL COMPLICATION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications POST PROCEDURAL HAEMATURIA	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 2 • On treatment (safety analysis set)
Injury, poisoning and procedural complications RADIUS FRACTURE	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Injury, poisoning and procedural complications ULNA FRACTURE	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications WOUND DEHISCENCE	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Injury, poisoning and procedural complications WRIST FRACTURE	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Injury, poisoning and procedural complications ACCIDENTAL OVERDOSE	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.13% 9/7002 • Number of events 9 • On treatment (safety analysis set)
Injury, poisoning and procedural complications ACETABULUM FRACTURE	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications ANASTOMOTIC LEAK	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications CRANIOCEREBRAL INJURY	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Injury, poisoning and procedural complications FRACTURED SACRUM	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications HAND FRACTURE	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications HEAD INJURY	0.14% 10/7012 • Number of events 10 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.13% 9/7002 • Number of events 9 • On treatment (safety analysis set)
Injury, poisoning and procedural complications INCISION SITE HAEMATOMA	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Injury, poisoning and procedural complications INJURY	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications JOINT DISLOCATION	0.10% 7/7012 • Number of events 7 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications LIGAMENT INJURY	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications MENISCUS LESION	0.04% 3/7012 • Number of events 4 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 5 • On treatment (safety analysis set)
Injury, poisoning and procedural complications MULTIPLE INJURIES	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications PERIPROSTHETIC FRACTURE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications POST CONCUSSION SYNDROME	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications PROCEDURAL PAIN	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Injury, poisoning and procedural complications SPINAL COLUMN INJURY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications SPINAL FRACTURE	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.07% 5/7002 • Number of events 5 • On treatment (safety analysis set)
Injury, poisoning and procedural complications SUBCUTANEOUS HAEMATOMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications TENDON RUPTURE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications TIBIA FRACTURE	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Injury, poisoning and procedural complications UPPER LIMB FRACTURE	0.10% 7/7012 • Number of events 7 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.09% 6/7002 • Number of events 6 • On treatment (safety analysis set)
Injury, poisoning and procedural complications WOUND	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Injury, poisoning and procedural complications ANAPHYLACTIC TRANSFUSION REACTION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications AORTIC INJURY	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications BLAST INJURY	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications BRAIN CONTUSION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications BURNS FOURTH DEGREE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications CHEMICAL PERITONITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications CLAVICLE FRACTURE	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications COMPRESSION FRACTURE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications ELECTRIC SHOCK	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications ESCHAR	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications EXCORIATION	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications EYE INJURY	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications FOREIGN BODY	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications FRACTURE DISPLACEMENT	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications IN-STENT ARTERIAL RESTENOSIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 2 • On treatment (safety analysis set)
Injury, poisoning and procedural complications IN-STENT CORONARY ARTERY RESTENOSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications INCISIONAL HERNIA	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications INTESTINAL ANASTOMOSIS COMPLICATION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications JAW FRACTURE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Injury, poisoning and procedural complications JOINT INJURY	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications LIGAMENT SPRAIN	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications MULTIPLE FRACTURES	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications MUSCLE INJURY	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications OVERDOSE	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications PERIORBITAL HAEMORRHAGE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications PERIRENAL HAEMATOMA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications PNEUMOTHORAX TRAUMATIC	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications POCKET EROSION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications POSTOPERATIVE ILEUS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications PROCEDURAL COMPLICATION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications RADIATION PNEUMONITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications SCAPULA FRACTURE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications SHUNT MALFUNCTION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Injury, poisoning and procedural complications SKELETAL INJURY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications SKIN INJURY	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications SKULL FRACTURE	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications TOOTH FRACTURE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications TRAUMATIC ARTHRITIS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications VASCULAR GRAFT OCCLUSION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Injury, poisoning and procedural complications VASCULAR INJURY	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications VASCULAR PSEUDOANEURYSM	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Injury, poisoning and procedural complications WOUND EVISCERATION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications WOUND HAEMORRHAGE	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications ABDOMINAL WOUND DEHISCENCE	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications AFFERENT LOOP SYNDROME	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications ANAEMIA POSTOPERATIVE	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications ANAESTHETIC COMPLICATION PULMONARY	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications ANASTOMOTIC HAEMORRHAGE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications ANASTOMOTIC ULCER	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications ARTERIAL INJURY	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications ARTERIAL RESTENOSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications BURNS SECOND DEGREE	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications BURNS THIRD DEGREE	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications CARBON MONOXIDE POISONING	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications CARDIAC PROCEDURE COMPLICATION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications CARTILAGE INJURY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications CEREBRAL HAEMORRHAGE TRAUMATIC	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications CHEST INJURY	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications EXTRADURAL HAEMATOMA	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications EYEBALL RUPTURE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications FACE INJURY	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications FRACTURE	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications FRACTURED COCCYX	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications FRACTURED ISCHIUM	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications GALLBLADDER INJURY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications GASTROSTOMY FAILURE	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications HAEMATURIA TRAUMATIC	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications HEAT ILLNESS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications INCISION SITE HAEMORRHAGE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications INTENTIONAL OVERDOSE	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications KIDNEY RUPTURE	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications LIMB CRUSHING INJURY	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Injury, poisoning and procedural complications LIMB INJURY	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications MUSCLE RUPTURE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Injury, poisoning and procedural complications OPEN WOUND	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications PERIORBITAL HAEMATOMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications POISONING	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications POST GASTRIC SURGERY SYNDROME	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications POST LAMINECTOMY SYNDROME	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications POST-TRAUMATIC PAIN	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications POSTOPERATIVE RESPIRATORY DISTRESS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications POSTPERICARDIOTOMY SYNDROME	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Injury, poisoning and procedural complications RADIATION SKIN INJURY	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications RENAL HAEMATOMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications RESPIRATORY FUME INHALATION DISORDER	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications SKULL FRACTURED BASE	0.01% 1/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications SOFT TISSUE INJURY	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications SPLENIC RUPTURE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications STERNAL FRACTURE	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications TENDON INJURY	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Injury, poisoning and procedural complications THERMAL BURN	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Injury, poisoning and procedural complications TRACHEAL INJURY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications TRANSFUSION REACTION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications TRAUMATIC INTRACRANIAL HAEMORRHAGE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Injury, poisoning and procedural complications TWIDDLER'S SYNDROME	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications URINARY RETENTION POSTOPERATIVE	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications VASCULAR GRAFT COMPLICATION	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications WOUND HAEMATOMA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications WOUND NECROSIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Injury, poisoning and procedural complications WOUND SECRETION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 2 • On treatment (safety analysis set)
Surgical and medical procedures AORTIC ANEURYSM REPAIR	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Surgical and medical procedures CARDIAC PACEMAKER REPLACEMENT	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Surgical and medical procedures COLECTOMY	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Surgical and medical procedures HIP ARTHROPLASTY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Surgical and medical procedures ARTHRODESIS	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Surgical and medical procedures EPIDURAL BLOOD PATCH	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Social circumstances IMMOBILE	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Social circumstances ACTIVITIES OF DAILY LIVING IMPAIRED	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Social circumstances CARDIAC ASSISTANCE DEVICE USER	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Social circumstances PHYSICAL DISABILITY	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders SLEEP APNOEA SYNDROME	0.06% 4/7012 • Number of events 4 • On treatment (safety analysis set)	0.10% 7/7012 • Number of events 7 • On treatment (safety analysis set)	0.09% 6/7002 • Number of events 7 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.10% 7/7002 • Number of events 9 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders PULMONARY HYPERTENSION	0.11% 8/7012 • Number of events 8 • On treatment (safety analysis set)	0.09% 6/7012 • Number of events 6 • On treatment (safety analysis set)	0.07% 5/7002 • Number of events 6 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders PULMONARY FIBROSIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders HAEMOTHORAX	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders RESPIRATORY DISTRESS	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.07% 5/7012 • Number of events 5 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 3 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY DISTRESS SYNDROME	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders ATELECTASIS	0.00% 0/7012 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders BRONCHOSPASM	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.04% 3/7002 • Number of events 4 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders PULMONARY CONGESTION	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders PULMONARY HAEMORRHAGE	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.04% 3/7012 • Number of events 4 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders ASPIRATION	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders BRONCHIECTASIS	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders CHRONIC RESPIRATORY FAILURE	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders LUNG DISORDER	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.06% 4/7002 • Number of events 4 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders ORGANISING PNEUMONIA	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders PULMONARY MASS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders PULMONARY TOXICITY	0.00% 0/7012 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders RESPIRATORY ARREST	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.03% 2/7012 • Number of events 2 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders ASPHYXIA	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders BRONCHIAL HYPERREACTIVITY	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders BRONCHOPNEUMOPATHY	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders COUGH	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders DYSPNOEA AT REST	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	0.04% 3/7012 • Number of events 3 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.11% 8/7002 • Number of events 9 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders EMPHYSEMA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders FOREIGN BODY ASPIRATION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders HYPOVENTILATION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders HYPOXIA	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.03% 2/7002 • Number of events 2 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders NASAL POLYPS	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.01% 1/7002 • Number of events 1 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders PULMONARY INFARCTION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders RESPIRATORY DISORDER	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders THORACIC HAEMORRHAGE	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders VOCAL CORD CYST	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders VOCAL CORD INFLAMMATION	0.00% 0/7012 • On treatment (safety analysis set)	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders ALLERGIC GRANULOMATOUS ANGIITIS	0.01% 1/7012 • Number of events 1 • On treatment (safety analysis set)	0.00% 0/7012 • On treatment (safety analysis set)	0.00% 0/7002 • On treatment (safety analysis set)

Other adverse events

Measure	Warfarin/Placebo Edoxaban n=7012 participants at risk Warfarin tablets plus placebo Edoxaban tablets warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months placebo edoxaban: placebo edoxaban	High Dose Edoxaban/Placebo Warfarin n=7012 participants at risk Edoxaban tablets plus warfarin placebo tablets Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	Low Dose Edoxaban/Placebo Warfarin n=7002 participants at risk Edoxaban tablets plus warfarin placebo tablets Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin
Infections and infestations urinary tract infection	10.0% 703/7012 • On treatment (safety analysis set)	9.8% 688/7012 • On treatment (safety analysis set)	10.0% 698/7002 • On treatment (safety analysis set)
Infections and infestations nasopharyngitis	8.8% 620/7012 • On treatment (safety analysis set)	8.8% 620/7012 • On treatment (safety analysis set)	9.2% 645/7002 • On treatment (safety analysis set)
Infections and infestations bronchitis	8.2% 572/7012 • On treatment (safety analysis set)	8.1% 567/7012 • On treatment (safety analysis set)	8.3% 584/7002 • On treatment (safety analysis set)
Infections and infestations upper respiratory tract infection	6.3% 445/7012 • On treatment (safety analysis set)	5.9% 411/7012 • On treatment (safety analysis set)	6.3% 443/7002 • On treatment (safety analysis set)
Blood and lymphatic system disorders anaemia	3.5% 242/7012 • On treatment (safety analysis set)	5.2% 368/7012 • On treatment (safety analysis set)	3.7% 261/7002 • On treatment (safety analysis set)
Nervous system disorders dizziness	8.4% 592/7012 • On treatment (safety analysis set)	7.3% 514/7012 • On treatment (safety analysis set)	7.7% 537/7002 • On treatment (safety analysis set)
Nervous system disorders headache	4.8% 336/7012 • On treatment (safety analysis set)	4.8% 334/7012 • On treatment (safety analysis set)	5.1% 356/7002 • On treatment (safety analysis set)
Cardiac disorders atrial fibrillation	7.0% 491/7012 • On treatment (safety analysis set)	6.8% 474/7012 • On treatment (safety analysis set)	7.5% 528/7002 • On treatment (safety analysis set)
Cardiac disorders cardiac failure	6.4% 448/7012 • On treatment (safety analysis set)	6.1% 425/7012 • On treatment (safety analysis set)	5.3% 373/7002 • On treatment (safety analysis set)
Vascular disorders hypertension	6.2% 438/7012 • On treatment (safety analysis set)	6.9% 481/7012 • On treatment (safety analysis set)	6.8% 475/7002 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders dyspnoea	6.7% 470/7012 • On treatment (safety analysis set)	6.5% 456/7012 • On treatment (safety analysis set)	6.2% 434/7002 • On treatment (safety analysis set)
Respiratory, thoracic and mediastinal disorders cough	5.2% 365/7012 • On treatment (safety analysis set)	5.5% 383/7012 • On treatment (safety analysis set)	5.9% 416/7002 • On treatment (safety analysis set)
Gastrointestinal disorders diarrhoea	7.1% 499/7012 • On treatment (safety analysis set)	6.9% 482/7012 • On treatment (safety analysis set)	6.9% 486/7002 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders back pain	6.8% 478/7012 • On treatment (safety analysis set)	6.8% 476/7012 • On treatment (safety analysis set)	7.1% 496/7002 • On treatment (safety analysis set)
Musculoskeletal and connective tissue disorders arthralgia	5.5% 386/7012 • On treatment (safety analysis set)	5.5% 385/7012 • On treatment (safety analysis set)	6.0% 417/7002 • On treatment (safety analysis set)
General disorders oedema peripheral	9.6% 675/7012 • On treatment (safety analysis set)	8.2% 577/7012 • On treatment (safety analysis set)	8.3% 578/7002 • On treatment (safety analysis set)
Injury, poisoning and procedural complications fall	8.1% 565/7012 • On treatment (safety analysis set)	6.5% 453/7012 • On treatment (safety analysis set)	6.5% 452/7002 • On treatment (safety analysis set)

Additional Information

James Hanyok, Sr. Director

Daiichi Sankyo, Inc.

Phone: 732-590-5000

Email: jhanyok@dsi.com

Results disclosure agreements

• Principal investigator is a sponsor employee A study site may not publish results of a study until after a coordinated multicenter publication has been submitted for publication or until one year after the study has ended, whichever occurs first. The study site will have the opportunity to publish results of the study, provided Daiichi Sankyo has had the opportunity to review and comment on the study site's proposed publication prior to being submitted for publication with the advice of patent council and need for subject protection.
• Publication restrictions are in place

Restriction type: OTHER