Trial Outcomes & Findings for Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL): A Trial To Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly In Patients With Type 2 Diabetes Mellitus (NCT NCT01144338)

NCT ID: NCT01144338

Last Updated: 2018-08-08

Results Overview

The primary efficacy outcome variable is defined as the composite endpoint of cardiovascular death, nonfatal MI, or nonfatal stroke. The number of participants who had an event is reported in the results. The primary efficacy endpoint is the same as the primary safety endpoint, and the statistical analysis tests the superiority of exenatide against the placebo.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 14752 participants
• Primary outcome timeframe: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
• Results posted on: 2018-08-08

Participant Flow

Participant milestones

Measure	Placebo Matching placebo subcutaneous injections	Exenatide Once Weekly Exenatide 2mg once weekly subcutaneous injections
Overall Study STARTED	7396	7356
Overall Study COMPLETED	7093	7094
Overall Study NOT COMPLETED	303	262

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL): A Trial To Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly In Patients With Type 2 Diabetes Mellitus

Baseline characteristics by cohort

Measure	Placebo n=7396 Participants Matching placebo subcutaneous injections	Exenatide Once Weekly n=7356 Participants Exenatide 2mg once weekly subcutaneous injections	Total n=14752 Participants Total of all reporting groups
Age, Continuous	61.9 Years STANDARD_DEVIATION 9.4 • n=5 Participants	61.8 Years STANDARD_DEVIATION 9.4 • n=7 Participants	61.9 Years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	2809 Participants n=5 Participants	2794 Participants n=7 Participants	5603 Participants n=5 Participants
Sex: Female, Male Male	4587 Participants n=5 Participants	4562 Participants n=7 Participants	9149 Participants n=5 Participants
Race/Ethnicity, Customized WHITE	5621 Participants n=5 Participants	5554 Participants n=7 Participants	11175 Participants n=5 Participants
Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN	436 Participants n=5 Participants	442 Participants n=7 Participants	878 Participants n=5 Participants
Race/Ethnicity, Customized ASIAN	727 Participants n=5 Participants	725 Participants n=7 Participants	1452 Participants n=5 Participants
Race/Ethnicity, Customized INDIAN (AMERICAN ) OR ALASKA NATIVE	35 Participants n=5 Participants	38 Participants n=7 Participants	73 Participants n=5 Participants
Race/Ethnicity, Customized NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Race/Ethnicity, Customized HISPANIC	557 Participants n=5 Participants	577 Participants n=7 Participants	1134 Participants n=5 Participants
Race/Ethnicity, Customized MISSING	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment Global · ASIA PACIFIC	760 Participants n=5 Participants	769 Participants n=7 Participants	1529 Participants n=5 Participants
Region of Enrollment Global · EUROPE	3399 Participants n=5 Participants	3389 Participants n=7 Participants	6788 Participants n=5 Participants
Region of Enrollment Global · LATIN AMERICA	1363 Participants n=5 Participants	1364 Participants n=7 Participants	2727 Participants n=5 Participants
Region of Enrollment Global · NORTH AMERICA	1874 Participants n=5 Participants	1834 Participants n=7 Participants	3708 Participants n=5 Participants
Prior CV Event Yes	5388 Participants n=5 Participants	5394 Participants n=7 Participants	10782 Participants n=5 Participants
Prior CV Event No	2008 Participants n=5 Participants	1962 Participants n=7 Participants	3970 Participants n=5 Participants

PRIMARY outcome

Timeframe: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

Population: ITT population: all patients consented and randomized in the study without a major GCP violation. ITT population is analyzed as randomized.

The primary efficacy outcome variable is defined as the composite endpoint of cardiovascular death, nonfatal MI, or nonfatal stroke. The number of participants who had an event is reported in the results.

The primary efficacy endpoint is the same as the primary safety endpoint, and the statistical analysis tests the superiority of exenatide against the placebo.

Outcome measures

Measure	Placebo n=7396 Participants Matching placebo subcutaneous injections	Exenatide Once Weekly n=7356 Participants Exenatide 2mg once weekly subcutaneous injections
Primary Efficacy Outcome MACE Events Number of patients who had a MACE event	905 Participants	839 Participants

PRIMARY outcome

Timeframe: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

Population: ITT population: all patients consented and randomized in the study without a major GCP violation. ITT population is analyzed as randomized.

The primary safety outcome variable is defined as the composite endpoint of cardiovascular death, nonfatal MI, or nonfatal stroke. The number of participants who had an event is reported in the results.

The primary safety endpoint is the same as the primary efficacy endpoints, and the statistical analysis tests the non-inferiority of exenatide against placebo.

Outcome measures

Measure	Placebo n=7396 Participants Matching placebo subcutaneous injections	Exenatide Once Weekly n=7356 Participants Exenatide 2mg once weekly subcutaneous injections
Primary Safety Outcome MACE Events Number of patients who had a MACE event	905 Participants	839 Participants

SECONDARY outcome

Timeframe: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

Population: ITT population: all patients consented and randomized in the study without a major GCP violation. ITT population is analyzed as randomized.

The secondary efficacy outcome variable is defined as the all-cause mortality (deaths). The number of participants who had an event is reported in the results.

Outcome measures

Measure	Placebo n=7396 Participants Matching placebo subcutaneous injections	Exenatide Once Weekly n=7356 Participants Exenatide 2mg once weekly subcutaneous injections
Secondary Efficacy Outcome All-Cause Mortality Number of patients who died	584 Participants	507 Participants

SECONDARY outcome

Timeframe: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

Population: ITT population: all patients consented and randomized in the study without a major GCP violation. ITT population is analyzed as randomized.

Component of the primary efficacy outcome: cardiovascular death. The number of participants who had an event is reported in the results.

Outcome measures

Measure	Placebo n=7396 Participants Matching placebo subcutaneous injections	Exenatide Once Weekly n=7356 Participants Exenatide 2mg once weekly subcutaneous injections
Secondary Efficacy Outcome CV Death Number of patients who had CV death	383 Participants	340 Participants

SECONDARY outcome

Timeframe: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

Population: ITT population: all patients consented and randomized in the study without a major GCP violation. ITT population is analyzed as randomized.

Component of primary efficacy outcome: fatal or non-fatal MI. The number of participants who had an event is reported in the results.

Outcome measures

Measure	Placebo n=7396 Participants Matching placebo subcutaneous injections	Exenatide Once Weekly n=7356 Participants Exenatide 2mg once weekly subcutaneous injections
Secondary Efficacy Outcome MI Number of patients who died	493 Participants	483 Participants

SECONDARY outcome

Timeframe: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

Population: ITT population: all patients consented and randomized in the study without a major GCP violation. ITT population is analyzed as randomized.

Component of primary efficacy outcome: fatal or non-fatal stroke. The number of participants who had an event is reported in the results.

Outcome measures

Measure	Placebo n=7396 Participants Matching placebo subcutaneous injections	Exenatide Once Weekly n=7356 Participants Exenatide 2mg once weekly subcutaneous injections
Secondary Efficacy Outcome Stroke Number of patients who had stroke	218 Participants	187 Participants

SECONDARY outcome

Timeframe: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

Population: ITT population: all patients consented and randomized in the study without a major GCP violation. ITT population is analyzed as randomized.

The secondary efficacy outcome variable is defined as hospitalization for acute coronary syndrome. The number of participants who had an event is reported in the results.

Outcome measures

Measure	Placebo n=7396 Participants Matching placebo subcutaneous injections	Exenatide Once Weekly n=7356 Participants Exenatide 2mg once weekly subcutaneous injections
Secondary Efficacy Outcome Hospitalization for ACS Num of pts with hospitalization due to ACS	570 Participants	602 Participants

SECONDARY outcome

Timeframe: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

Population: ITT population: all patients consented and randomized in the study without a major GCP violation. ITT population is analyzed as randomized.

The secondary efficacy outcome variable is defined as hospitalization for heart failure. The number of participants who had an event is reported in the results.

Outcome measures

Measure	Placebo n=7396 Participants Matching placebo subcutaneous injections	Exenatide Once Weekly n=7356 Participants Exenatide 2mg once weekly subcutaneous injections
Secondary Efficacy Outcome Hospitalization for HF Number of patients who died	231 Participants	219 Participants

Adverse Events

Placebo

Serious events: 1222 serious events

Other events: 0 other events

Deaths: 584 deaths

Exenatide Once Weekly

Serious events: 1234 serious events

Other events: 0 other events

Deaths: 507 deaths

Serious adverse events

Measure	Placebo n=7372 participants at risk Matching placebo subcutaneous injections	Exenatide Once Weekly n=7344 participants at risk Exenatide 2mg once weekly subcutaneous injections
Gastrointestinal disorders Abdominal strangulated hernia	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Abdominal wall haematoma	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Anal fissure	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Anal fistula	0.01% 1/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Anal haemorrhage	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Anorectal stenosis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Anorectal varices	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Ascites	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Chronic gastritis	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Colitis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Colitis ischaemic	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Constipation	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Crohn's disease	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Diaphragmatic hernia	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Diverticular perforation	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Diverticulum	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Diverticulum intestinal	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.03% 2/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Duodenal ulcer	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.05% 4/7344 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Duodenitis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Duodenitis haemorrhagic	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Dyspepsia	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Dysphagia	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.05% 4/7344 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Enterocele	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Ear and labyrinth disorders Tympanic membrane disorder	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Ear and labyrinth disorders Tympanic membrane perforation	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Ear and labyrinth disorders Vertigo	0.08% 6/7372 • Number of events 6 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.08% 6/7344 • Number of events 7 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Ear and labyrinth disorders Vertigo positional	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.08% 6/7344 • Number of events 6 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Ear and labyrinth disorders Vestibular disorder	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Endocrine disorders Adrenal mass	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Endocrine disorders Autoimmune thyroiditis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Endocrine disorders Cushing's syndrome	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Endocrine disorders Goitre	0.04% 3/7372 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.10% 7/7344 • Number of events 7 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Endocrine disorders Hyperaldosteronism	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Endocrine disorders Hyperthyroidism	0.03% 2/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Endocrine disorders Hypothyroidism	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Endocrine disorders Thyroid disorder	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Endocrine disorders Thyroid mass	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Endocrine disorders Toxic nodular goitre	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Eye disorders Angle closure glaucoma	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Eye disorders Blindness unilateral	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Eye disorders Cataract	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Eye disorders Diplopia	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Eye disorders Extraocular muscle disorder	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Eye disorders Eye disorder	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Eye disorders Eye pain	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Eye disorders Glaucoma	0.01% 1/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Eye disorders Lens dislocation	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Eye disorders Macular fibrosis	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Eye disorders Macular hole	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Eye disorders Macular oedema	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Eye disorders Open angle glaucoma	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Eye disorders Retinal detachment	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.05% 4/7344 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Eye disorders Retinal haemorrhage	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Eye disorders Ulcerative keratitis	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Eye disorders Visual impairment	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Eye disorders Vitreous haemorrhage	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Abdominal adhesions	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Abdominal hernia	0.08% 6/7372 • Number of events 6 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.10% 7/7344 • Number of events 7 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Abdominal incarcerated hernia	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Abdominal pain	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Abdominal pain upper	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Enterocutaneous fistula	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Epigastric discomfort	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Erosive oesophagitis	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Faecaloma	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Gastric antral vascular ectasia	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Gastric fistula	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Gastric perforation	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Gastric polyps	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Gastric ulcer	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.05% 4/7344 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Gastric ulcer perforation	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Gastric varices haemorrhage	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Gastritis	0.16% 12/7372 • Number of events 12 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.05% 4/7344 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Gastritis erosive	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Gastroduodenal haemorrhage	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Renal and urinary disorders Urinary tract obstruction	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Reproductive system and breast disorders Acquired phimosis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Reproductive system and breast disorders Atrophic vulvovaginitis	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.15% 11/7372 • Number of events 11 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.12% 9/7344 • Number of events 9 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Reproductive system and breast disorders Breast mass	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Reproductive system and breast disorders Cervical dysplasia	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Reproductive system and breast disorders Cystocele	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Reproductive system and breast disorders Endometrial hyperplasia	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Reproductive system and breast disorders Epididymal cyst	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Reproductive system and breast disorders Female genital tract fistula	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Reproductive system and breast disorders Genital lesion	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Reproductive system and breast disorders Gynaecomastia	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Reproductive system and breast disorders Menorrhagia	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Reproductive system and breast disorders Organic erectile dysfunction	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Reproductive system and breast disorders Ovarian cyst	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Reproductive system and breast disorders Ovarian vein thrombosis	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Reproductive system and breast disorders Postmenopausal haemorrhage	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Reproductive system and breast disorders Prostatitis	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Reproductive system and breast disorders Prostatomegaly	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Reproductive system and breast disorders Uterine haemorrhage	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Reproductive system and breast disorders Uterine polyp	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Reproductive system and breast disorders Uterine prolapse	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Acquired diaphragmatic eventration	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.14% 10/7372 • Number of events 10 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.11% 8/7344 • Number of events 8 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Alveolitis allergic	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Asthma	0.05% 4/7372 • Number of events 6 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.07% 5/7344 • Number of events 6 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Asthmatic crisis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.66% 49/7372 • Number of events 81 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.65% 48/7344 • Number of events 84 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Cough	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.24% 18/7372 • Number of events 18 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.15% 11/7344 • Number of events 13 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Emphysema	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.05% 4/7372 • Number of events 6 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Hiccups	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.09% 7/7372 • Number of events 7 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Nasal septum perforation	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Nasal turbinate hypertrophy	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.14% 10/7372 • Number of events 10 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.12% 9/7344 • Number of events 10 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Pleural fibrosis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Blood and lymphatic system disorders Haemorrhagic anaemia	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Blood and lymphatic system disorders Immune thrombocytopenic purpura	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Blood and lymphatic system disorders Iron deficiency anaemia	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.15% 11/7344 • Number of events 13 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Blood and lymphatic system disorders Lymphadenopathy mediastinal	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Blood and lymphatic system disorders Mastocytosis	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Blood and lymphatic system disorders Microcytic anaemia	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Blood and lymphatic system disorders Neutropenia	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Cardiac disorders Angina pectoris	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Cardiac disorders Myocardial ischaemia	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Congenital, familial and genetic disorders Arteriovenous malformation	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Congenital, familial and genetic disorders Gastrointestinal arteriovenous malformation	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Congenital, familial and genetic disorders Haemorrhagic arteriovenous malformation	0.01% 1/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Congenital, familial and genetic disorders Hydrocele	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Congenital, familial and genetic disorders Phimosis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Congenital, familial and genetic disorders Rathke's cleft cyst	0.01% 1/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Congenital, familial and genetic disorders Sacralisation	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Congenital, familial and genetic disorders Thalassaemia beta	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Ear and labyrinth disorders Acute vestibular syndrome	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Ear and labyrinth disorders Deafness	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Ear and labyrinth disorders Hypoacusis	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Ear and labyrinth disorders Mixed deafness	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Blood and lymphatic system disorders Anaemia	0.35% 26/7372 • Number of events 31 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.20% 15/7344 • Number of events 16 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Blood and lymphatic system disorders Antiphospholipid syndrome	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Blood and lymphatic system disorders Autoimmune haemolytic anaemia	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Blood and lymphatic system disorders Bone marrow disorder	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Blood and lymphatic system disorders Bone marrow oedema	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Blood and lymphatic system disorders Coagulopathy	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Blood and lymphatic system disorders Febrile neutropenia	0.03% 2/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Blood and lymphatic system disorders Haemolytic anaemia	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Renal and urinary disorders Urinary incontinence	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.46% 34/7372 • Number of events 37 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.37% 27/7344 • Number of events 30 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Gastrointestinal hypomotility	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Gastrointestinal inflammation	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Gastrointestinal melanosis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Gastrointestinal obstruction	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.12% 9/7372 • Number of events 10 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.08% 6/7344 • Number of events 8 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Gingival bleeding	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Haematochezia	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Haemorrhoids	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Hiatus hernia	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Ileus	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Impaired gastric emptying	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Incarcerated umbilical hernia	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Inflammatory bowel disease	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Inguinal hernia	0.05% 4/7372 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.12% 9/7344 • Number of events 9 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Intestinal haematoma	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Intestinal haemorrhage	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Intestinal obstruction	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.05% 4/7344 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Intestinal perforation	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Jejunal perforation	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Large intestinal ulcer	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Large intestinal ulcer haemorrhage	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Large intestine perforation	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Large intestine polyp	0.14% 10/7372 • Number of events 11 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.12% 9/7372 • Number of events 9 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Lumbar hernia	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Mallory-weiss syndrome	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Melaena	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Oesophageal obstruction	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Oesophageal perforation	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Oesophageal polyp	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Oesophageal ulcer	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Oesophagitis	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Renal and urinary disorders Urinary retention	0.09% 7/7372 • Number of events 8 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.05% 4/7344 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Oral dysaesthesia	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Oroantral fistula	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Pancreatic cyst	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Pancreatic mass	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Pancreatitis	0.30% 22/7372 • Number of events 24 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.50% 37/7344 • Number of events 37 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Peptic ulcer	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Peritoneal haematoma	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Rectal haemorrhage	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.07% 5/7344 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Rectal polyp	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Rectourethral fistula	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Retroperitoneal haematoma	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Retroperitoneal haemorrhage	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Retroperitoneal mass	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Small intestinal obstruction	0.11% 8/7372 • Number of events 9 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.10% 7/7344 • Number of events 7 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Small intestinal perforation	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Strangulated umbilical hernia	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Subileus	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Tongue haemorrhage	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Umbilical hernia	0.19% 14/7372 • Number of events 14 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.07% 5/7344 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.14% 10/7372 • Number of events 10 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.12% 9/7344 • Number of events 9 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Gastrointestinal disorders Varices oesophageal	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
General disorders Adverse drug reaction	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
General disorders Asthenia	0.07% 5/7372 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.05% 4/7344 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
General disorders Chest discomfort	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
General disorders Chest pain	0.07% 5/7372 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.07% 5/7344 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
General disorders Complication associated with device	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
General disorders Cyst	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
General disorders Drug interaction	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
General disorders Fatigue	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
General disorders Gait disturbance	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
General disorders General physical health deterioration	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
General disorders Generalised oedema	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
General disorders Granuloma	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
General disorders Haemorrhagic cyst	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
General disorders Hernia	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
General disorders Impaired healing	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
General disorders Impaired self-care	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
General disorders Injection site inflammation	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
General disorders Malaise	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
General disorders Non-cardiac chest pain	1.1% 79/7372 • Number of events 90 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	1.2% 87/7344 • Number of events 104 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
General disorders Oedema	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
General disorders Oedema peripheral	0.05% 4/7372 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
General disorders Pain	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
General disorders Polyp	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
General disorders Pyrexia	0.07% 5/7372 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
General disorders Strangulated hernia	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Hepatobiliary disorders Acute hepatic failure	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Hepatobiliary disorders Bile duct stenosis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Hepatobiliary disorders Biliary cirrhosis	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Hepatobiliary disorders Biliary colic	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Hepatobiliary disorders Biliary cyst	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Hepatobiliary disorders Chronic hepatic failure	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Hepatobiliary disorders Cirrhosis alcoholic	0.01% 1/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Hepatobiliary disorders Gallbladder fistula	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Hepatobiliary disorders Gallbladder polyp	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Hepatobiliary disorders Hepatic cirrhosis	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.05% 4/7344 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Hepatobiliary disorders Hepatic haematoma	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Hepatobiliary disorders Hepatic lesion	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Hepatobiliary disorders Hepatic mass	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Hepatobiliary disorders Hepatomegaly	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Hepatobiliary disorders Hepatosplenomegaly	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Hepatobiliary disorders Jaundice	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Hepatobiliary disorders Jaundice cholestatic	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Hepatobiliary disorders Liver injury	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Hepatobiliary disorders Portal vein thrombosis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Immune system disorders Anaphylactic reaction	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Immune system disorders Drug hypersensitivity	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Immune system disorders Food allergy	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Immune system disorders Hypersensitivity	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Immune system disorders Sarcoidosis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Infections and infestations Bronchitis	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Infections and infestations Cellulitis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Infections and infestations Chronic sinusitis	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Infections and infestations Chronic tonsillitis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Infections and infestations Cystitis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Infections and infestations Dengue fever	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Infections and infestations Endophthalmitis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Infections and infestations Epiglottitis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Infections and infestations Hepatitis e	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Infections and infestations Herpes zoster	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Infections and infestations Herpes zoster oticus	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Infections and infestations Keratouveitis	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Infections and infestations Pseudomembranous colitis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Infections and infestations Pulmonary tuberculosis	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Infections and infestations Sinusitis	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Infections and infestations Vestibular neuronitis	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Infections and infestations Viral infection	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Accident	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Accidental overdose	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Acetabulum fracture	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Alcohol poisoning	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Anastomotic ulcer	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Ankle fracture	0.09% 7/7372 • Number of events 7 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.15% 11/7344 • Number of events 11 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Arthropod sting	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Brain contusion	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Carbon monoxide poisoning	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Comminuted fracture	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Complicated fracture	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Concussion	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Contrast media reaction	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Contusion	0.05% 4/7372 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Craniocerebral injury	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Ear injury	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Exposure to toxic agent	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Extradural haematoma	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Eye injury	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Facial bones fracture	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.05% 4/7344 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Fall	0.19% 14/7372 • Number of events 15 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.16% 12/7344 • Number of events 12 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Femoral neck fracture	0.08% 6/7372 • Number of events 6 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.14% 10/7344 • Number of events 10 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Femur fracture	0.18% 13/7372 • Number of events 14 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.12% 9/7344 • Number of events 9 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Fibula fracture	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Foot fracture	0.05% 4/7372 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.05% 4/7344 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Forearm fracture	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Foreign body	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Gastrointestinal anastomotic leak	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Haematuria traumatic	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Hand fracture	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Head injury	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Hepatic haematoma	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Hip fracture	0.08% 6/7372 • Number of events 6 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.19% 14/7344 • Number of events 14 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Humerus fracture	0.12% 9/7372 • Number of events 10 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.14% 10/7344 • Number of events 10 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Ilium fracture	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Incarcerated incisional hernia	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Incisional hernia	0.05% 4/7372 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Injury	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Intentional overdose	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Joint dislocation	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Laceration	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Ligament injury	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Limb injury	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Lower limb fracture	0.07% 5/7372 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.05% 4/7344 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.05% 4/7344 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Meniscus injury	0.09% 7/7372 • Number of events 7 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.08% 6/7344 • Number of events 7 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Multiple fractures	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Multiple injuries	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Muscle injury	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Muscle rupture	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Nail injury	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Overdose	0.09% 7/7372 • Number of events 7 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.07% 5/7344 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Patella fracture	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.08% 6/7344 • Number of events 6 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Periprosthetic fracture	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Perirenal haematoma	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Post laminectomy syndrome	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Post procedural haematoma	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Postoperative fever	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Postoperative ileus	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Postoperative respiratory failure	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Postoperative thoracic procedure complication	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Postoperative wound complication	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Procedural haemorrhage	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Procedural pneumothorax	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Pubis fracture	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Radiation pneumonitis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Radius fracture	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Rib fracture	0.19% 14/7372 • Number of events 14 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.07% 5/7344 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Road traffic accident	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Scapula fracture	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Seroma	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Skin injury	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Skull fractured base	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Soft tissue injury	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Spinal column injury	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Spinal compression fracture	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.07% 5/7344 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Spinal cord injury cervical	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Spinal fracture	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Splenic injury	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Splenic rupture	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Subdural haematoma	0.12% 9/7372 • Number of events 9 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.15% 11/7344 • Number of events 11 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Subdural haemorrhage	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Tendon rupture	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.05% 4/7344 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Thermal burn	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Tibia fracture	0.11% 8/7372 • Number of events 8 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.11% 8/7344 • Number of events 8 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Toxicity to various agents	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.05% 4/7344 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Traumatic haemothorax	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Traumatic liver injury	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Ulna fracture	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Upper limb fracture	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.10% 7/7344 • Number of events 7 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Wound	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Wound dehiscence	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Wound evisceration	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Injury, poisoning and procedural complications Wrist fracture	0.03% 2/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Investigations Anticoagulation drug level increased	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Investigations Blood calcitonin increased	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Investigations Blood potassium decreased	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Investigations Eosinophil count increased	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Investigations Hiv test positive	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Investigations International normalised ratio abnormal	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Investigations International normalised ratio increased	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Investigations Weight decreased	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Metabolism and nutrition disorders Acidosis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Metabolism and nutrition disorders Dehydration	0.11% 8/7372 • Number of events 8 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.14% 10/7344 • Number of events 10 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Metabolism and nutrition disorders Electrolyte imbalance	0.07% 5/7372 • Number of events 6 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Metabolism and nutrition disorders Fluid overload	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Metabolism and nutrition disorders Hypercalcaemia	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Metabolism and nutrition disorders Hyperkalaemia	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.07% 5/7344 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Metabolism and nutrition disorders Hypernatraemia	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Metabolism and nutrition disorders Hypocalcaemia	0.01% 1/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Metabolism and nutrition disorders Hypokalaemia	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Metabolism and nutrition disorders Hyponatraemia	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.11% 8/7344 • Number of events 9 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Metabolism and nutrition disorders Hypovolaemia	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Metabolism and nutrition disorders Lactic acidosis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Metabolism and nutrition disorders Lactose intolerance	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Metabolism and nutrition disorders Obesity	0.12% 9/7372 • Number of events 10 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Ankylosing spondylitis	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Arthralgia	0.12% 9/7372 • Number of events 10 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.07% 5/7344 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Arthritis	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.08% 6/7344 • Number of events 6 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Arthrofibrosis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Arthropathy	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Articular calcification	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Back pain	0.16% 12/7372 • Number of events 14 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.19% 14/7344 • Number of events 15 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Chest wall haematoma	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Costochondritis	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Crystal arthropathy	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Deformity thorax	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Exostosis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Foot deformity	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Fracture nonunion	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.03% 2/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Intervertebral disc compression	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.05% 4/7372 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.05% 4/7372 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.07% 5/7344 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.23% 17/7372 • Number of events 19 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.20% 15/7344 • Number of events 18 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Intervertebral disc space narrowing	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Joint adhesion	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Joint effusion	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Joint instability	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.27% 20/7372 • Number of events 21 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.16% 12/7344 • Number of events 13 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Meniscal degeneration	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Monarthritis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Muscle spasms	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Muscular weakness	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.07% 5/7372 • Number of events 6 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.14% 10/7344 • Number of events 13 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Musculoskeletal deformity	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.08% 6/7372 • Number of events 6 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Myopathy	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Neck pain	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Neuropathic arthropathy	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.1% 79/7372 • Number of events 89 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.94% 69/7344 • Number of events 76 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Osteochondritis	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Pain in extremity	0.05% 4/7372 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Pathological fracture	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Periarthritis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Periostitis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Polyarthritis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Rheumatic disorder	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.12% 9/7372 • Number of events 9 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.07% 5/7344 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Sacroiliitis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.14% 10/7372 • Number of events 10 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.05% 4/7344 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Spinal disorder	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.12% 9/7372 • Number of events 10 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.15% 11/7344 • Number of events 13 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Spinal pain	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Spondyloarthropathy	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.08% 6/7372 • Number of events 6 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Synovial cyst	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Synovitis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Tendon pain	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Musculoskeletal and connective tissue disorders Vertebral osteophyte	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acth-producing pituitary tumour	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.05% 4/7372 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of appendix	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.12% 9/7372 • Number of events 9 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.16% 12/7344 • Number of events 12 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenoma benign	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal adenoma	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal neoplasm	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Angiosarcoma	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Appendix cancer	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.34% 25/7372 • Number of events 33 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.34% 25/7344 • Number of events 42 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basosquamous carcinoma	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign gastric neoplasm	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign laryngeal neoplasm	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign lung neoplasm	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of bladder	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of thyroid gland	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign oesophageal neoplasm	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign ovarian tumour	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign salivary gland neoplasm	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign small intestinal neoplasm	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.09% 7/7372 • Number of events 8 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.12% 9/7344 • Number of events 9 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer recurrent	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 6 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer stage 0, with cancer in situ	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder papilloma	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.07% 5/7372 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.05% 4/7344 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma recurrent	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone cancer	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.05% 4/7344 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm malignant	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer female	0.19% 14/7372 • Number of events 14 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.22% 16/7344 • Number of events 16 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer male	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast neoplasm	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carotid body tumour	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cerebral haemangioma	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma recurrent	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Choroid melanoma	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myeloid leukaemia	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell endometrial carcinoma	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.05% 4/7372 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.12% 9/7372 • Number of events 9 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.22% 16/7344 • Number of events 16 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.07% 5/7344 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage i	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenocarcinoma	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Desmoplastic melanoma	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large b-cell lymphoma	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ear neoplasm	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.07% 5/7344 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenoma	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.05% 4/7344 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Epithelioid mesothelioma	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Essential thrombocythaemia	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Extradural neoplasm	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibroma	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibrosarcoma	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder cancer	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric adenoma	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.07% 5/7344 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric neoplasm	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal carcinoma	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stromal tumour	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal submucosal tumour	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma multiforme	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioblastoma	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hairy cell leukaemia	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic adenoma	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.08% 6/7372 • Number of events 6 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.07% 5/7372 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.05% 4/7344 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.05% 4/7344 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal squamous cell carcinoma	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip neoplasm	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip squamous cell carcinoma	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.05% 4/7344 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.05% 4/7372 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma metastatic	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.08% 6/7372 • Number of events 6 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.08% 6/7344 • Number of events 6 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage iv	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.16% 12/7372 • Number of events 12 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.16% 12/7344 • Number of events 12 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma metastatic	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant anorectal neoplasm	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant ascites	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.09% 7/7372 • Number of events 8 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.11% 8/7344 • Number of events 8 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of unknown primary site	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mantle cell lymphoma	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesothelioma	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesothelioma malignant	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to adrenals	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastasis	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic renal cell carcinoma	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic uterine cancer	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myeloid leukaemia	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myeloproliferative neoplasm	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasal sinus cancer	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm prostate	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma of the skin	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine tumour	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-hodgkin's lymphoma	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer metastatic	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer stage iv	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal cancer metastatic	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oropharyngeal cancer	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oropharyngeal squamous cell carcinoma	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian adenoma	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian neoplasm	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.20% 15/7372 • Number of events 15 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.20% 15/7344 • Number of events 15 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neuroendocrine tumour	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary cystadenoma lymphomatosum	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paraproteinaemia	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour benign	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Penile cancer	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Peripheral t-cell lymphoma unspecified	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.07% 5/7372 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.07% 5/7344 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.35% 26/7372 • Number of events 26 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.27% 20/7344 • Number of events 20 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer recurrent	0.03% 2/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage i	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.05% 4/7372 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenoma	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.05% 4/7344 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer metastatic	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal neoplasm	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectosigmoid cancer	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.09% 7/7372 • Number of events 7 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.07% 5/7344 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.05% 4/7344 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal oncocytoma	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Respiratory papilloma	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Retinal melanoma	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland cancer	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sinonasal papilloma	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine carcinoma	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Spinal meningioma benign	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.18% 13/7372 • Number of events 16 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.16% 12/7344 • Number of events 15 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of head and neck	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.05% 4/7344 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.11% 8/7372 • Number of events 8 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.10% 7/7344 • Number of events 8 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the hypopharynx	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the oral cavity	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the tongue	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.09% 7/7372 • Number of events 7 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.19% 14/7344 • Number of events 14 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm malignant stage unspecified	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer metastatic	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.09% 7/7372 • Number of events 7 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.07% 5/7344 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma urethra	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vulval cancer	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Xanthogranuloma	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Altered state of consciousness	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Amputation stump pain	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Asterixis	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Ataxia	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Autonomic neuropathy	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Brain injury	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Carpal tunnel syndrome	0.05% 4/7372 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.07% 5/7344 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Cauda equina syndrome	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Cerebellar haemorrhage	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Cerebellar syndrome	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Cerebral haemorrhage	0.07% 5/7372 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Cerebrospinal fluid leakage	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Cervical myelopathy	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Cervical radiculopathy	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Cervicobrachial syndrome	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Cervicogenic headache	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Cognitive disorder	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Coma	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Coordination abnormal	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Dementia	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Dementia alzheimer's type	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Demyelinating polyneuropathy	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Dizziness	0.12% 9/7372 • Number of events 9 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.07% 5/7344 • Number of events 6 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Encephalopathy	0.05% 4/7372 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.05% 4/7344 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Epilepsy	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.07% 5/7344 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Facial paralysis	0.08% 6/7372 • Number of events 6 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.05% 4/7344 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Facial paresis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Frontotemporal dementia	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Generalised tonic-clonic seizure	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Guillain-barre syndrome	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Haemorrhage intracranial	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Headache	0.04% 3/7372 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Hepatic encephalopathy	0.04% 3/7372 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.05% 4/7344 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Hydrocephalus	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Hypoaesthesia	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Hypotonia	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Iiird nerve paralysis	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Idiopathic generalised epilepsy	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Intracranial aneurysm	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Intracranial pressure increased	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Loss of consciousness	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Lumbar radiculopathy	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Lumbosacral radiculopathy	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Memory impairment	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Metabolic encephalopathy	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Migraine	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.08% 6/7344 • Number of events 6 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Mixed dementia	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Multiple sclerosis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Myasthenia gravis	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Myelitis transverse	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Nerve compression	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Nerve root compression	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Neuralgia	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Neuralgic amyotrophy	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Neuritis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Neurodegenerative disorder	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Neuropathy peripheral	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Normal pressure hydrocephalus	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Paraesthesia	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Parkinsonism	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Partial seizures	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Post herpetic neuralgia	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Post stroke seizure	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Radicular syndrome	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Restless legs syndrome	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Sciatica	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.05% 4/7344 • Number of events 4 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Seizure	0.14% 10/7372 • Number of events 10 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.08% 6/7344 • Number of events 7 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Senile dementia	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Spinal claudication	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Spinal cord compression	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Spondylitic myelopathy	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Status epilepticus	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Subacute combined cord degeneration	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Subarachnoid haemorrhage	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Subdural hygroma	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Toxic encephalopathy	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Trigeminal neuralgia	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Vith nerve paralysis	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Vascular dementia	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Vascular headache	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Nervous system disorders Vertebrobasilar insufficiency	0.05% 4/7372 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Pregnancy, puerperium and perinatal conditions Cephalhaematoma	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Pregnancy, puerperium and perinatal conditions Cephalo-pelvic disproportion	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Product Issues Device battery issue	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Product Issues Device dislocation	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Product Issues Device failure	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Product Issues Device loosening	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Product Issues Device malfunction	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Product Issues Device occlusion	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Product Issues Patient-device incompatibility	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Psychiatric disorders Alcohol abuse	0.03% 2/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Psychiatric disorders Alcoholism	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Psychiatric disorders Anxiety	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Psychiatric disorders Bipolar disorder	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Psychiatric disorders Confusional state	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Psychiatric disorders Delirium	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Psychiatric disorders Depressed mood	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Psychiatric disorders Depression	0.19% 14/7372 • Number of events 15 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.08% 6/7344 • Number of events 7 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Psychiatric disorders Depression suicidal	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Psychiatric disorders Major depression	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Psychiatric disorders Mental status changes	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.10% 7/7344 • Number of events 7 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Psychiatric disorders Personality change due to a general medical condition	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Psychiatric disorders Post-traumatic stress disorder	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Psychiatric disorders Psychogenic seizure	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Psychiatric disorders Psychotic disorder	0.01% 1/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Psychiatric disorders Suicidal ideation	0.01% 1/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Psychiatric disorders Suicide attempt	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Renal and urinary disorders Acute kidney injury	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Renal and urinary disorders Azotaemia	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Renal and urinary disorders Bladder discomfort	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Renal and urinary disorders Bladder diverticulum	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Renal and urinary disorders Bladder mass	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Renal and urinary disorders Calculus bladder	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Renal and urinary disorders Calculus urethral	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Renal and urinary disorders Calculus urinary	0.07% 5/7372 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Renal and urinary disorders Dysuria	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Renal and urinary disorders Glomerulonephritis chronic	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Renal and urinary disorders Haematuria	0.09% 7/7372 • Number of events 7 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.08% 6/7344 • Number of events 6 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Renal and urinary disorders Hydronephrosis	0.05% 4/7372 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Renal and urinary disorders Hypertonic bladder	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Renal and urinary disorders Hypotonic urinary bladder	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Renal and urinary disorders Nephrolithiasis	0.18% 13/7372 • Number of events 13 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.20% 15/7344 • Number of events 16 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Renal and urinary disorders Nephrosclerosis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Renal and urinary disorders Obstructive uropathy	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Renal and urinary disorders Pelvi-ureteric obstruction	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Renal and urinary disorders Renal colic	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.11% 8/7344 • Number of events 8 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Renal and urinary disorders Renal cyst	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Renal and urinary disorders Renal cyst haemorrhage	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Renal and urinary disorders Renal impairment	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Renal and urinary disorders Renal mass	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Renal and urinary disorders Stress urinary incontinence	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Renal and urinary disorders Ureteric stenosis	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Renal and urinary disorders Ureterolithiasis	0.07% 5/7372 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.14% 10/7344 • Number of events 10 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Renal and urinary disorders Urethral haemorrhage	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Renal and urinary disorders Urethral stenosis	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.04% 3/7344 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Renal and urinary disorders Urinary bladder polyp	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.18% 13/7372 • Number of events 14 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.16% 12/7344 • Number of events 13 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Restrictive pulmonary disease	0.03% 2/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.08% 6/7372 • Number of events 7 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.10% 7/7344 • Number of events 7 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Stridor	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Tracheal stenosis	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Tracheomalacia	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Skin and subcutaneous tissue disorders Angioedema	0.07% 5/7372 • Number of events 7 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.07% 5/7344 • Number of events 5 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Skin and subcutaneous tissue disorders Dermatitis bullous	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Skin and subcutaneous tissue disorders Drug eruption	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Skin and subcutaneous tissue disorders Drug reaction with eosinophilia and systemic symptoms	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Skin and subcutaneous tissue disorders Granuloma skin	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Skin and subcutaneous tissue disorders Ingrowing nail	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Skin and subcutaneous tissue disorders Keloid scar	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Skin and subcutaneous tissue disorders Lichen planus	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Skin and subcutaneous tissue disorders Lichenoid keratosis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Skin and subcutaneous tissue disorders Parapsoriasis	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Skin and subcutaneous tissue disorders Prurigo	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Skin and subcutaneous tissue disorders Psoriasis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Skin and subcutaneous tissue disorders Rash	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Skin and subcutaneous tissue disorders Rash generalised	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Skin and subcutaneous tissue disorders Skin ulcer	0.01% 1/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Skin and subcutaneous tissue disorders Stasis dermatitis	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Skin and subcutaneous tissue disorders Umbilical haemorrhage	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Social circumstances Alcohol use	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Vascular disorders Arterial rupture	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Vascular disorders Bleeding varicose vein	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Vascular disorders Haematoma	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.11% 8/7344 • Number of events 8 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Vascular disorders Haemorrhage	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Vascular disorders Lymphocele	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Vascular disorders Peripheral artery thrombosis	0.01% 1/7372 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Vascular disorders Post thrombotic syndrome	0.00% 0/7372 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.01% 1/7344 • Number of events 1 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Vascular disorders Temporal arteritis	0.01% 1/7372 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.00% 0/7344 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
Vascular disorders Varicose vein	0.04% 3/7372 • Number of events 3 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.	0.03% 2/7344 • Number of events 2 • During study period up to 7.5 years Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.

Other adverse events

Adverse event data not reported

Additional Information

Peter Ohman

Astrazaneca Inc.

Phone: 1(301)398-0120

Email: Peter.Ohman@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place